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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03686930




Registration number
NCT03686930
Ethics application status
Date submitted
10/04/2018
Date registered
27/09/2018
Date last updated
27/09/2018

Titles & IDs
Public title
Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045
Scientific title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally to Normal, Healthy Volunteers
Secondary ID [1] 0 0
FP045C-17-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cohort 1 - FP-045 oral solution
Treatment: Drugs - Cohort 2 - FP-045 oral solution
Treatment: Drugs - Cohort 3 - FP-045 oral solution
Treatment: Drugs - Placebo (for FP-045 oral solution)

Active Comparator: Cohort 1 - FP-045 oral solution - FP-045 powder for oral solution, will be reconstituted once daily (QD) dose, administered for 7 consecutive days.

Placebo Comparator: Cohort 1 - Placebo for FP-045 oral solution - Placebo oral solution that is identical to the test product, but without FP-045.

Active Comparator: Cohort 2 - FP-045 oral solution - FP-045 powder for oral solution (escalated dose), will be reconstituted once daily (QD) dose, administered for 7 consecutive days.

Placebo Comparator: Cohort 2 - Placebo for FP-045 oral solution - Placebo oral solution that is identical to the test product, but without FP-045.

Active Comparator: Cohort 3 - FP-045 oral solution - FP-045 powder for oral solution (escalated dose), will be reconstituted once daily (QD) dose, administered for 7 consecutive days.

Placebo Comparator: Cohort 3 - Placebo for FP-045 oral solution - Placebo oral solution that is identical to the test product, but without FP-045.


Treatment: Drugs: Cohort 1 - FP-045 oral solution
FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.

Treatment: Drugs: Cohort 2 - FP-045 oral solution
FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.

Treatment: Drugs: Cohort 3 - FP-045 oral solution
FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.

Treatment: Drugs: Placebo (for FP-045 oral solution)
Participants (cohorts 1-3) will receive FP-045 oral solution matching placebo.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in baseline measures for vital sign parameters [safety/tolerability] - Outcome Measures units of measure include weight in kilograms.
Timepoint [1] 0 0
14 days ± 2 days
Primary outcome [2] 0 0
Change in baseline measures for ECG parameters [safety/tolerability] - T wave
Timepoint [2] 0 0
14 days ± 2 days
Primary outcome [3] 0 0
Change in baseline measures for clinical laboratory test [safety/tolerability] - Number of Participants with Abnormal Laboratory Values. Blood will be drawn to measure the chemistry of the blood prior to and after dosing.
Timepoint [3] 0 0
14 days ± 2 days
Primary outcome [4] 0 0
Number of participants with treatment-emergent ECG abnormalities [safety/tolerability].
Timepoint [4] 0 0
14 days ± 2 days
Primary outcome [5] 0 0
Number of participants with treatment-emergent AEs [safety/tolerability].
Timepoint [5] 0 0
14 days ± 2 days
Primary outcome [6] 0 0
Number of participants with treatment-emergent AEs leading to premature discontinuation of study drug [safety/tolerability].
Timepoint [6] 0 0
14 days ± 2 days
Primary outcome [7] 0 0
Number of participants with treatment-emergent SAEs [safety/tolerability].
Timepoint [7] 0 0
14 days ± 2 days
Primary outcome [8] 0 0
Change in baseline measures for vital sign parameters [safety/tolerability] - Outcome Measures units of measure include height in meters.
Timepoint [8] 0 0
14 days ± 2 days
Primary outcome [9] 0 0
Change in baseline measures for vital sign parameters [safety/tolerability] - Outcome Measures units of measure include blood pressure both systolic and diastolic will be measured.
Timepoint [9] 0 0
14 days ± 2 days
Secondary outcome [1] 0 0
Pharmacokinetic (PK) profile (Cmax) following multiple, escalating oral doses of FP-045. - Cmax (maximum plasma concentration) —first and last doses (Day 1 and Day 7) of FP-045 will be measured.
Timepoint [1] 0 0
14 days ± 2 days
Secondary outcome [2] 0 0
Pharmacokinetic (PK) profile (Tmax) following multiple, escalating oral doses of FP-045. - Tmax (time to maximum plasma concentration) —first and last doses (Day 1 and Day 7) of FP-045 will be measured.
Timepoint [2] 0 0
14 days ± 2 days
Secondary outcome [3] 0 0
Pharmacokinetic (PK) profile (AUC0-24) following multiple, escalating oral doses of FP-045. - AUC0-24 (area under the curve from time 0 to 24 hours postdose) - first dose (Day 1) of FP-045 will be measured.
Timepoint [3] 0 0
14 days ± 2 days
Secondary outcome [4] 0 0
Pharmacokinetic (PK) profile (Cavg) following multiple, escalating oral doses of FP-045. - Cavg (average plasma concentration over the dosing interval) = AUC0-24/t, where t is the dosing interval - last dose (Day 7) of FP-045 will be measured.
Timepoint [4] 0 0
14 days ± 2 days
Secondary outcome [5] 0 0
Pharmacokinetic (PK) profile (accumulation ratio of AUC0-24) following multiple, escalating oral doses of FP-045. - Accumulation ratio of AUC0-24 (Day 7)/AUC0-24 (Day 1) of FP-045 will be measured.
Timepoint [5] 0 0
14 days ± 2 days
Secondary outcome [6] 0 0
Pharmacokinetic (PK) profile (AUC[0-24]) following multiple, escalating oral doses of FP-045. - AUC[0-24](area under the curve over the dosing interval) - Day 7 of FP-045 will be measured.
Timepoint [6] 0 0
14 days ± 2 days
Secondary outcome [7] 0 0
Other pharmacokinetic (PK) profiles measured include t1/2 (terminal half-life) following multiple, escalating oral doses of FP-045.
Timepoint [7] 0 0
14 days ± 2 days
Secondary outcome [8] 0 0
Other pharmacokinetic (PK) profiles measured include CL/F (apparent clearance) following multiple, escalating oral doses of FP-045.
Timepoint [8] 0 0
14 days ± 2 days
Secondary outcome [9] 0 0
Other pharmacokinetic (PK) profiles measured include Vz/F (apparent volume of distribution) following multiple, escalating oral doses of FP-045.
Timepoint [9] 0 0
14 days ± 2 days
Secondary outcome [10] 0 0
Other pharmacokinetic (PK) profiles measured include elimination rate constant following multiple, escalating oral doses of FP-045.
Timepoint [10] 0 0
14 days ± 2 days

Eligibility
Key inclusion criteria
1. Male or female NHV, age 18 to 55 years, inclusive (at the time of informed consent).

2. Females must be either postmenopausal for =1 year (or with FSH = 40 mIU/mL if
postmenopausal for < 1 year) or surgically sterile (having undergone bilateral tubal
ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months.

3. Males with female partners of childbearing potential must agree to use barrier
contraceptive (i.e., condom) and their female partners must use a highly effective
method of contraception from Screening through 90 days after the last dose of study
drug. Males must also refrain from sperm donations during this time period.

Males who are abstinent will not be required to use a contraceptive method unless they
become sexually active.

4. The subject is, in the opinion of the Investigator, generally healthy based on
assessment of medical history, physical examination, vital signs, electrocardiogram
(ECG), and the results of the hematology, clinical chemistry, urinalysis, serology,
and other laboratory tests.

5. Baseline laboratory test values within reference ranges based on the blood and urine
samples taken at Screening and on Day -1 (before administration of the initial study
drug). Out of normal ranges values may be accepted by the Investigator, if not
clinically significant.

6. Nonsmoker and/or ex-smoker who has discontinued smoking and/or use of nicotine
containing products for at least 6 months prior to the first dose of study drug

7. Body mass index between 18 and 30 kg/m2, inclusive

8. Written informed consent obtained Ability to communicate well with the Investigator,
in the local language, and to understand and comply with the requirements of the
study.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or presence of any clinically significant neurological, metabolic,
gastrointestinal, endocrinological (in particular diabetes or pre-diabetes),
cardiovascular, hematological, hepatic, immunological, renal, respiratory, chronic
infections, psychiatric, or genitourinary abnormalities or diseases. Note: NHVs with a
history of uncomplicated kidney stones or asthma may be enrolled in the study at the
discretion of the Investigator.

2. History of malignant neoplastic disease, with the following exceptions:

1. Adequately treated non-melanomatous skin carcinoma

2. Female with a history of benign cervical carcinoma neoplasia if compliant with
surveillance and treatment as recommended by her physician

3. Mentally or legally incapacitated, has significant emotional problems at Screening or
expected during the conduct of the study, or has a history of a clinically significant
psychiatric disorder within the last 5 years. Note: NHVs who have had situational
depression may be enrolled in the study at the discretion of the Investigator.

4. The subject has a history of severe drug allergy or hypersensitivity or food allergy,
including anaphylaxis.

5. The subject has had surgery or trauma with significant blood loss within the last 3
months prior to the first dose of study drug.

6. The subject has donated blood more than 1 unit (500 mL) with 4 weeks prior to the
first dose of study drug.

7. Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2
weeks prior to Screening

8. Blood pressure >140/90 mm Hg or heart rate >100 beats per minute at Screening or at
Day -1. Vitals may be repeated up to 2 times for the purpose of eligibility.

9. Clinically significant laboratory abnormalities including:

1. Impaired renal function (serum creatinine levels >ULN) at Screening; estimated
creatinine clearance (CrCl) of <80 mL/min

2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory
values >1.2 × upper normal limits

10. Clinically significant abnormality on ECG performed at Screening or prior to
administration of the initial dose of study drug. (Screening ECG conduction intervals
must be 10. Clinically significant abnormality on ECG performed at Screening or prior
to administration of the initial dose of study drug. (Screening ECG conduction
intervals must be within gender specific normal ranges [QT interval corrected for
heart rate [QTc] males =450 msec and females =470 msec].)

11. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human
immunodeficiency virus antibody at Screening

12. Positive screen for drugs with a high potential for abuse (amphetamine, cannabinoid,
cocaine, morphine, and phencyclidine) at Screening and Study Day -1.

13. Consumed food or drink containing grapefruit juice within 72 hours before start of
dosing or expected to do so through EOS/ET

14. Consumed alcohol within 72 hours before start of dosing through EOS/ET.

15. Received any previous FP-045 or has taken any investigational product within 30 days
or 5 half-lives (whichever is longer) prior to the first dose of study drug.

16. Female who is breastfeeding or has a positive pregnancy test

17. Unwilling or unable to comply with the requirements of this protocol, including the
presence of any condition (physical, mental, or social) that is likely to affect the
subject's return for the scheduled EOS Visit

18. The subject has taken prescription medications within 2 weeks (or within 5 half-lives,
whichever is longer) or nonprescription medication, herbal remedies, vitamins or
minerals within 1 week prior to the administration of the initial dose of study drug
and continuing throughout the study until the final study visit. Note: There may be
certain medications that are permitted at the discretion of the Investigator and
Sponsor (including paracetamol/ acetaminophen, which may be used for minor ailments
during the course of the study without prior consultation with the Sponsor's Medical
Monitor).

19. The subject exercises extensively (e.g. marathon, triathlon or other similar high
energetic sports). In general, subjects should refrain from sporting for at least 4
days before participation in the study until the EOS/ET visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Networks - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Foresee Pharmaceuticals Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase I, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose
(MAD), study to evaluate the safety/tolerability and pharmacokinetics (PK) of FP-045
administered to normal health volunteers (NHVs). 3 cohorts of NHVs will be enrolled. Subjects
in each cohort will be randomized to orally receive either FP-045 (6 subjects) or placebo (2
subjects). Subjects will receive 7 daily doses of study drug.

Subjects will be screened for study eligibility within 21 days before Day 1 and will have
been admitted to the CRU on Day -1 to confirm eligibility and to undergo baseline
assessments. Subjects will remain in the CRU for observation until completion of all
assessments on Day 10. Subjects will return to the CRU on Day 11 for an additional PK sample,
and again for an end of study (EOS) Visit on Day 14 (±2 days) for safety evaluations and
collection of PK samples.
Trial website
https://clinicaltrials.gov/show/NCT03686930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Lau, Ph.D.
Address 0 0
Foresee Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications