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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02134834




Registration number
NCT02134834
Ethics application status
Date submitted
7/05/2014
Date registered
9/05/2014
Date last updated
12/12/2014

Titles & IDs
Public title
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.
Secondary ID [1] 0 0
OP0595-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OP0595
Treatment: Drugs - Placebo

Experimental: Ascending single dose of OP0595 -

Placebo Comparator: Normal Saline -


Treatment: Drugs: OP0595
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

Treatment: Drugs: Placebo
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation

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

Outcomes
Primary outcome [1] 0 0
Safety from baseline through the end of the study - Number of patients with adverse events
Timepoint [1] 0 0
Day 1 to Day 7
Secondary outcome [1] 0 0
Plasma PK parameters of OP0595 and its metabolites - Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss
Timepoint [1] 0 0
Day 1 to Day 2
Secondary outcome [2] 0 0
Urine PK parameters of OP0595 and its metabolites - Ae, Ae0-t, Ae0-t/Dose, CLr
Timepoint [2] 0 0
Day 1 to Day 2

Eligibility
Key inclusion criteria
- Caucasian males aged between 18 and 45 years (inclusive) at Screening

- A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening

- Good general health as determined by the Investigator based on medical history,
physical examination, vital signs, 12-lead ECG and clinical laboratory tests

- Negative urine test for drugs of abuse and breath test for alcohol both at Screening
and Day -1
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Receipt of any investigational agent or drug within four months before Screening

- A history or current evidence of allergic symptoms such as bronchial asthma,
drug-induced rash or urticaria

- Hypersensitivity and/or allergy to drugs

- Concurrent or history of clinically significant cardiovascular, hepatic, renal,
endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological
disorders

- A history of chronic or recurrent infections or current active infection

- A recent history of surgery within three months prior to Screening, determined by the
Investigator to be clinically relevant

- A history or presence of malignancy

- Donation of blood (or loss of blood) greater than 400 ml within three months before
Screening

- A history of smoking at any time within one year before Screening

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 analysing the results/data
Intervention assignment
Parallel
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)
WA
Recruitment hospital [1] 0 0
- Perth,
Recruitment postcode(s) [1] 0 0
- Perth,

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Meiji Seika Pharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this study are to assess the safety, tolerability and pharmacokinetic
profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at
single escalating doses.
Trial website
https://clinicaltrials.gov/show/NCT02134834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mitsuharu Egawa
Address 0 0
Meiji Seika Pharma Co., Ltd.
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