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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00958152