HIV-1 infection MedDRA version: 19.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: 3TC® (Lamivudine)
Product Name: Lamivudine
Pharmaceutical Form: Tablet
INN or Proposed INN: LAMIVUDINE
CAS Number: 134678-17-4
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy, non-smoking, male and female subjects, from 18 to 55 years of age. 2) BMI =19.0 and =30.0 kg/m2. 3) Females who participate in this study will be of childbearing or non-childbearing potential: • Childbearing potential: Physically capable of becoming pregnant • Non-childbearing potential: Surgically sterile (i.e., both ovaries removed, uterus removed or bilateral tubal ligation); and/or Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause). 4) Willing to use acceptable, effective methods of contraception. 5) Subjects provide written informed consent/assent for the trial, including for Future Biomedical Research. 6) Able to drink approximately 480 mL of water and 50 mL of whole milk in 30 minutes. 7) Able to tolerate venipuncture. 8) Be informed of the nature of the study and give written consent prior to any study procedure. 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
Exclusion criteria: 1) Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2) Known or suspected carcinoma. 3) Known history or presence of hypersensitivity or idiosyncratic reaction to lamivudine or tenofovir or any other drug substances with similar activity. 4) 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. 5) 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. Subjects who have had situational depression may be enrolled in the study at the discretion of the Investigator. 6) Presence of mouth piercings (object or hole), presence of non-removable dentures and orthodontic appliances (e.g., braces, retainers), or any other alteration to the mouth that may be deemed by the Investigator to compromise drug delivery. 7) History of any surgery on the oral cavity or throat in the past year. 8) Known history or presence of galactose or fructose intolerance, sucraseisomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome. 9) Presence of hepatic or renal dysfunction. 10) Estimated creatinine clearance of =80 mL/min based on the Cockcroft- Gault equation 11) History of malabsorption within the last year or presence of clinically significant gastrointestinal disease. 12) Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption. 13) History of drug or alcohol addiction requiring treatment. 14) Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody. 15) Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine. 16) Difficulty fasting or consuming standard meals. 17) Use of tobacco or nicotine-containing products within 6 months prior to the first drug administration. 18) Females who: • Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to the first drug administration; • Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration; • Are pregnant (serum hCG consistent with pregnancy); or • Are lactating. 19) Donation or loss of whole blood (including clinical trials): • =50 mL and <500 mL within 30 days prior to the first drug administration; • =500 mL within 56 days prior to the first drug administration. 20) Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to the first drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results. 21) On a special diet within 30 days prior to drug administration (e.g., liquid, protein,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the comparative bioavailability of: 1.lamivudine 300mg: a. adult marketed tablets to the investigational oral pediatric uncoated/coated granules-fasted conditions b.investigational oral pediatric uncoated granules-fasted conditions, to the investigational oral pediatric uncoated granules-fasted conditions+vanilla pudding/applesauce c.investigational oral pediatric coated granules-fasted conditions, to the investigational oral pediatric coated granules-fasted conditions+vanilla pudding/applesauce 2.tenofovir 300mg: a.adult marketed tablets to the investigational oral pediatric uncoated/coated granules - under fasted conditions b.investigational oral pediatric uncoated granules-fasted conditions, to the investigational oral pediatric uncoated granules-fasted conditions+vanilla pudding/applesauce c.investigational oral pediatric coated granules-fasted conditions, to the investigational oral pediatric coated granules - fasted conditions+vanilla pudding/applesauce ;Secondary Objective: Not applicable;Primary end point(s): The following pharmacokinetic parameters will be estimated using a non-compartmental approach for lamivudine and tenofovir: C24, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2, ?z, CL/F, and Vz/F;Timepoint(s) of evaluation of this end point: In each period, prior to (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after first drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Canada
Contacts
Public ContactMartin Otto Behm
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed