Raltegravir/Lamivudine Drug Interaction Study

• Conditions: HIV-1 Infection; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2015-002237-22-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1)Male or female subjects 18-55 years of age at screening. Female subjects of reproductive potential must demonstrate a serum beta-hCG level consistent with the nongravid state at screening and agree to use 2 acceptable methods of birth control from prestudy until 2 weeks after the last dose of study drug in the last treatment period.
2)Subject has a Body Mass Index (BMI) = 31 kg/m2 at screening.
3)Subject judged to be in good health based on medical history, physical examination, vital signs, ECG and laboratory safety tests performed at screening and prior to administration of the initial dose of study drug.
4)Subject has been a non-smoker and/or has not used nicotine or nicotine-containing products for at least ~6 months; subjects who have discontinued smoking or the use of nicotine/nicotine-containing products for at least ~3 months may be enrolled at the discretion of the investigator.
5)Subject understands the study procedures and agrees to participate in the study by giving written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Subject is mentally or legally incapacitated, has significant emotional problems at screening or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years.
2)Subject has an estimated creatinine clearance of ? 80 mL/min based on the Cockcroft-Gault equation.
3)Subject has a history of stroke, chronic seizures or major neurological disorder.
4)Subject has a history of neoplastic disease.
5)Subject has a history of gastric disease, including peptic ulcer disease or gastric surgery.
6)Subject has a history of liver disease, including chronic hepatitis, or elevated liver enzymes above normal limits at screening.
7)Subject is unable to refrain from the use of any prescription or nonprescription drugs or preparations within 2 weeks prior or 5 half-lives to the first dose of study drug and during the entire study.
8)Subject consumes excessive amounts of alcohol and/or caffeine.
9)Subject participated in another investigational study within 4 weeks prior to screening.
10)Subject has a history of significant multiple and/or severe allergies.
11)Subject is currently a regular user of any illicit drugs or has a history of drug abuse within ~5 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the plasma pharmacokinetic profiles of raltegravir and lamivudine after administration of MK-0518B (Formulation #6) and coadministration of the marketed Isentress 400 mg and Epivir 150 mg tablets.<br>;Secondary Objective: Not applicable;Primary end point(s): The plasma pharmacokinetic parameters (e.g., AUC , Cmax, C12hr, Tmax, apparent t1/2) of raltegravir and lamivudine after co-administration of Isentress 400 mg and Epivir 150 mg fasted, MK-0518B-#6 300 mg/150 mg tablet fasted will be determined.;Timepoint(s) of evaluation of this end point: Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours after drug administration.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable