Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects
This study has been completed.
Sponsor:
Pfizer
Collaborator:
ViiV Healthcare
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01220232
First received: October 12, 2010
Last updated: February 3, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This will be an open-label, fixed-sequence, multiple dose crossover study in 14 healthy male and/or female subjects, to estimate the effect of steady state lersivirine on the steady state pharmacokinetics of abacavir/lamivudine.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Abacavir/Lamivudine Drug: Lersivirine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label, Fixed-Sequence, Crossover Study To Estimate The Effect Of Lersivirine On The Pharmacokinetics Of Abacavir/Lamivudine In Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To estimate the effect of steady state lersivirine 750 mg on the steady state pharmacokinetics of abacavir/lamivudine. [ Time Frame: 17 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To investigate the safety and tolerability of lersivirine when co-administered with abacavir/lamivudine. [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | November 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Abacavir/Lamivudine |
Drug: Abacavir/Lamivudine
Abacavir/Lamivudine 600/300 mg QD for 5 days
|
| Experimental: Lersivirine + Abacavir/Lamivudine |
Drug: Abacavir/Lamivudine
Abacavir/Lamivudine 600/300 mg QD for 10 days
Drug: Lersivirine
Lersivirine 750 mg QD for 10 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and/or female subjects.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >50 kg (110 lbs).
Exclusion Criteria:
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- History of hypersensitivity to abacavir, lamivudine and/or lersivirine.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01220232 History of Changes |
| Other Study ID Numbers: | A5271048 |
| Study First Received: | October 12, 2010 |
| Last Updated: | February 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Lersivirine UK-453 061 NNRTI Abacavir Lamivudine |
Combivir Pharmacokinetics Drug Interaction HIV AIDS |
Additional relevant MeSH terms:
|
Lamivudine Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013