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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00958152




Registration number
NCT00958152
Ethics application status
Date submitted
6/08/2009
Date registered
13/08/2009
Date last updated
7/01/2010

Titles & IDs
Public title
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
Secondary ID [1] 0 0
VX09-222-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VCH-222
Treatment: Drugs - VCH-222
Treatment: Drugs - VCH-222
Treatment: Drugs - telaprevir

Experimental: Cohort 1 -

Experimental: Cohort 2 -

Experimental: Cohort 3 -


Treatment: Drugs: VCH-222
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37

Treatment: Drugs: VCH-222
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37

Treatment: Drugs: VCH-222
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37

Treatment: Drugs: telaprevir
Tablet, Oral, 1125 mg, q12h, Days 18-37
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
Timepoint [1] 0 0
Day 47 safety assessment
Secondary outcome [1] 0 0
Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state
Timepoint [1] 0 0
Day 37 pharmacokinetic assessment
Secondary outcome [2] 0 0
Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state
Timepoint [2] 0 0
Day 37 pharmacokinetic assessment

Eligibility
Key inclusion criteria
- Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55
years (inclusive)

- Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight > 50 kg
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Women of child bearing potential

- Subjects positive for Hepatitis B, Hepatitis C, or HIV

- Subjects who have participated in a clinical study involving administration of an
investigational drug within 2 months

Study design
Purpose of the study
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 administering the treatment/s
The people assessing the outcomes
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
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of
the co-administration of VCH-222 and telaprevir in healthy subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00958152
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Vertex Pharmaceuticals Incorporated
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00958152