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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03108274




Registration number
NCT03108274
Ethics application status
Date submitted
28/03/2017
Date registered
11/04/2017
Date last updated
16/06/2017

Titles & IDs
Public title
A Phase I DDI Study Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil
Scientific title
A Three-Part Phase I Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects
Secondary ID [1] 0 0
U1111-1193-2774
Secondary ID [2] 0 0
ACH471-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug Interaction Potentiation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Part 1, Period 1
Treatment: Drugs - Part 1, Period 2
Treatment: Drugs - Part 2, Period 1
Treatment: Drugs - Part 2, Period 2
Treatment: Drugs - Part 3, Period 1
Treatment: Drugs - Part 3, Period 2

Experimental: Part 1, Period 1 - Single oral dose of Midazolam Day 1

Experimental: Part 1, Period 2 - Multiple oral doses of ACH-0144471 Day 1-4 Single oral single dose of Midazolam on Day 4

Experimental: Part 2, Period 1 - Single dose of Fexofenadine on Day 1

Experimental: Part 2, Period 2 - Multiple doses of ACH-0144471 on Days 1-6 Single dose of Fexofenadine on Day 4

Experimental: Part 3, Period 1 - Single dose of Mycophenolate Mofetil on Day 1

Experimental: Part 3, Period 2 - Multiple doses of ACH-0144471 on Days 1-6 Single dose of Mycophenolate Mofetil on Day 4


Treatment: Drugs: Part 1, Period 1
Midazolam single oral dose

Treatment: Drugs: Part 1, Period 2
Multiple doses ACH-0144471 Single dose Midazolam

Treatment: Drugs: Part 2, Period 1
Fexofenadine single oral dose

Treatment: Drugs: Part 2, Period 2
Multiple doses ACH-0144471 Single dose Fexofenadine

Treatment: Drugs: Part 3, Period 1
Mycophenolate Mofetil single oral dose

Treatment: Drugs: Part 3, Period 2
Multiple doses ACH-0144471 Single dose Mycophenolate Mofetil

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

Outcomes
Primary outcome [1] 0 0
Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil - To determine the effect of multiple oral doses of ACH-0144471 on the pharmacokinetics (PK) of midazolam, fexofenadine and mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) as measured by maximum observed concentration (Cmax)
Timepoint [1] 0 0
Up to 26 Days
Primary outcome [2] 0 0
Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil - To determine the effect of multiple oral doses of ACH-0144471 on the pharmacokinetics (PK) of midazolam, fexofenadine and mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPAG) as measured by area under the curve (AUC)
Timepoint [2] 0 0
Up to 26 Days
Secondary outcome [1] 0 0
Drug Interaction Between ACH-0144471 and Midazolam - To assess the safety and tolerability of multiple oral doses of ACH-0144471 with midazolam measured by adverse events (AE's), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG)
Timepoint [1] 0 0
Up to 26 Days
Secondary outcome [2] 0 0
Drug Interaction Between ACH-0144471 and Fexofenadine - To assess the safety and tolerability of multiple oral doses of ACH-0144471 with fexofenadine measured by adverse events (AE's), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG)
Timepoint [2] 0 0
Up to 26 Days
Secondary outcome [3] 0 0
Drug Interaction Between ACH-0144471 and Mycophenolate Mofetil - To assess the safety and tolerability of multiple oral doses of ACH-0144471 with mycophenolate mofetil measured by adverse events (AE's), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG)
Timepoint [3] 0 0
Up to 26 Days

Eligibility
Key inclusion criteria
- Healthy male and female subjects age 18-60

- Have a BMI of 18.5 to 32 kg/m2 with a minimum body weight of 50kg

- Females must be of non-childbearing potential

- Males must agree to use effective contraception during and for 90 days after last dose
of study drug

- Willing to answer inclusion and exclusion criteria

- Give voluntary consent

- Willing to comply with visit schedule and all procedures and tests
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Mentally or legally incapacitated or significant emotional problems

- History of disease

- Any condition which might interfere with drug absorption

- Positive test for HIV, Hepatitis B and/or C

- History of sensitivity to study medication, or other drug allergy

- Body temperature greater than 38 Celsius

- History of febrile illness within 14 days of first dose

- History of meningococcal infection

- Positive urine drug test

- Current tobacco users and smokers

- Consumption of alcohol within 72 hours of study drug administration

- Participated in another clinical study within 28 days prior to first dose

- Previous participation in an ACH-0144471 study

- 12-lead ECG with significant findings

- Significant laboratory abnormalities

- Use of prescription medications within 14 days of first dose

- Use of medications known to induce hepatic microsomal enzyme cytochrome

- Prior history or current evidence of biliary cholestasis

- Blood donation of more than 500mL within 3 months of first dose

- Received a blood transfusion or blood products within 6 months to first dose

- Unwilling or unable to comply with study protocol

- Males subjects with female partner who is pregnant, nursing or planning to become
pregnant within 90 days of last study dose

- Received live attenuated vaccine within 30 days or other vaccine within 14 days of
first dose

- Have or history of Gilberts syndrome

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
Open (masking not used)
Who is / are masked / blinded?



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 outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Achillion Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the potential drug interaction between ACH-0144471
and Midazolam, Fexofenadine and Mycophenolate Mofetil
Trial website
https://clinicaltrials.gov/show/NCT03108274
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Hamilton, MD
Address 0 0
Auckland Clinical Studies Limited
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