N/A
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy, non-smoking, male or female subjects, from 18 to 55 years of age. 2)BMI = 19.0 and = 30.0 kg/m2. 3)No clinically significant findings in vital signs measurements, laboratory values, 12-lead electrocardiogram (ECG) and physical examination. 4)Have no significant diseases. 5)Males who participate in this study are willing to: • remain abstinent [not engage in sexual intercourse] from drug administration until 28 days after the end of the study or • use (or their partner will use, as applicable) two effective methods of birth control [condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, vasectomy, or hormonal contraceptives] from drug administration until 28 days after the end of the study. Females who participate in this study are: • unable to have children (for example, post-menopausal, hysterectomy); • willing to remain abstinent [not engage in sexual intercourse] from 21 days prior to drug administration until 28 days after the end of the study; or • willing to use two effective methods of birth control [condom, diaphragm, cervical cap, vaginal sponge, spermicide, IUD, tubal ligation, partner has vasectomy, hormonal contraceptives for 3 months prior to drug administration] from 21 days prior to drug administration until 28 days after the end of the study. 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Known or suspected carcinoma. 2)Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years. 3)An estimated creatinine clearance of = 80 mL/min based on the Cockcroft-Gault equation. An actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of, or in conjunction with, the Cockcroft-Gault equation; subjects who have an actual or estimated creatinine clearance within 10% below 80 mL/min may be enrolled at the discretion of the investigator. 4)A history of liver disease, including chronic hepatitis, or elevated liver enzymes above normal limits at screening. 5)Presence of clinically significant gastrointestinal disease (e.g. peptic ulcer disease or gastric surgery) or history of malabsorption within the last year. 6)Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. 7)History of drug or alcohol addiction requiring treatment. 8)Positive test result for serum hCG consistent with pregnancy (females only), HIV, Hepatitis B surface antigen or Hepatitis C antibody. 9)Positive test result for urine drugs of abuse or urine cotinine. 10)Females who are lactating. 11)Does not tolerate venipuncture. 12)Use of tobacco or nicotine-containing products within 6 months prior to drug administration. 13)On a special diet within 30 days prior to drug administration (for example, liquid, protein, raw food diet). 14)Participated in another clinical trial or received an investigational product within 30 days prior to drug administration. 15)Donation or loss of whole blood: • = 50 mL and = 499 mL within 30 days prior to drug administration • = 500 mL within 56 days prior to drug administration. 16)Females who have started taking hormonal contraceptives or have changed their method or brand of hormonal birth control within 3 months prior to drug administration. 17)Have had a tattoo or body piercing within 30 days prior to drug administration. 18)History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. 19)Known history or presence of hypersensitivity or idiosyncratic reaction to raltegravir, lamivudine or any other drug substances with similar activity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the effect of a high-fat meal on the in vivo performance of Raltegravir/lamivudine (MK-0518B) 300 mg/150 mg Fixed-Dose Combination (FDC) tablets from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA after a single-dose in healthy subjects.;Secondary Objective: N/A;Primary end point(s): Pharmacokinetics (e.g., AUCt, AUCinf, Cmax and C12) of raltegravir and lamivudine after administration of the FDC with a high-fat meal and under fasting conditions.;Timepoint(s) of evaluation of this end point: Prior to dosing (0-hour) and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: N/A;Secondary end point(s): N/A | — |
Countries
Canada
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed