VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.

NCT00775125 | Completed Phase 1

• 1 other identifier: CR015208
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objectives are to determine the effect of steady-state DRV/rtv 600/100 mg twice daily (b.i.d.) on the steady-state pharmacokinetics of telaprevir 750 mg every (q) 8h and 1125 mg q12h and vice versa;- to determine the effect at steady-state of fAPV/rtv 700/100 mg b.i.d. on the steady-state pharmacokinetics of telaprevir 750 mg q8h and 1125 mg q 12h and vice versa; to determine the steady-state pharmacokinetics of telaprevir 750 mg q8h versus telaprevir 1125 mg q12h, alone and during coadministration of either steady-state DRV/rtv 600/100 mg b.i.d or fAPV/rtv 700/100 mg b.i.d.

Conditions

Hepatitis C; Telaprevir; HIV

Keywords

VX-950-TiDP24-C124; VX-950-C124; HCV; DDI; telaprevir; darunavir; ritonavir; fosamprenavir; interaction; pharmacokinetics; steady-state

Outcome Measures

Primary Outcomes (1)

• Effect of steady-state DRV/rtv 600/100 mg b.i.d. and steady-state of fAPV/rtv 700/100 mg on the steady-state PK of telaprevir 750 mg q8h and 1125 mg q12h and vice versa. Steady-state PK on telaprevir 750 mg q8h and 1125 mg q12h alone.

Secondary Outcomes (1)

• The secondary objective is to determine the short-term safety and tolerability of coadministration of telaprevir and DRV/rtv, and telaprevir and fAPV/rtv.

Interventions

Telaprevir; Darunavir; Ritonavir; Fosamprenavir DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females in menopause for at least 3 years or surgically sterilized
• Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to screening
• Normal weight at screening as defined by a body mass index (BMI) of 18 to 30 kg/m2, extremes included
• Able to comply with protocol requirements
• Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening.

You may not qualify if:

• Subjects must not have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering trial drug(s) to the subject
• Subjects should currently not use prescription medication. Subjects should stop any short-duration courses of prescription medication at least 14 days before the screening visit. Potential subjects should not stop any chronic, prescribed medication being taken at the direction of a physician, without obtaining agreement from that physician
• Subjects should not have regular treatment with over-the-counter medications. Subjects should stop over-the-counter medications on the date of the screening visit but no less than 7 days prior to the first administration of study medication (Day 1 of Session I). Potential subjects should not stop any chronic, over-the-counter medication being taken at the direction of a physician, without obtaining agreement from that physician
• Subjects should not consumeherbal medications or dietary supplements and grapefruit or grapefruit juice, apple juice, or orange juice within 14 days before the first administration of study medication (Day 1 of Session I)
• Subjects should not have a history of drug or alcohol abuse or addiction within 2 years prior to dosing, or who test positive for alcohol or drugs such as amphetamine, barbiturates, benzodiazepines, cocaine, cannabinoids, opioids, metamphetamine and methadone during the screening period
• Subject should not have participated in a clinical study involving administration of an investigational drug within 3 months or 5 half lives (whichever is longer) prior to the screening visit.

Sponsors & Collaborators

• Tibotec BVBA: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir; Darunavir; Ritonavir; fosamprenavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles

Study Officials

• Tibotec-Virco Virology BVBA Clinical Trial

  Tibotec BVBA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 17, 2010

Record last verified: 2010-12