A Study to Compare the Pharmacokinetics of a Fixed-Dose Combination of Raltegravir and Lamivudine to Co-administered Raltegravir and Lamivudine - Raltegravir/Lamivudine Drug Interaction Study

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 24 人开始时间: 2015年5月22日最近更新: 2015年7月10日

试验速览

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•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

•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.

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