Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: ViiV Healthcare
• Treatments: Abacavir; Dideoxynucleosides; Dolutegravir; Lamivudine; Triumeq

Criteria

Inclusion Criteria - Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

• 18 to 55 years old.

• Males and/or females not of child-bearing potential.

• Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 19.0 kg/m2.

• Adequate venous access in both arms.

• Only non-tobacco/non-nicotine subjects.

• Able to understand and sign the written Informed Consent Form.

• Willing to follow the protocol requirements and comply with protocol restrictions.

• All subjects should be judged by the Principal Investigator or Medical Sub- Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication.

Exclusion Criteria - Subject candidates must not be enrolled in the study if subject meet any of the following criteria:

• Institutionalized subjects.

• Social Habits, Medications and Diseases will be evaluated.

• Use of certain foods and processed candies, gums food/drinks that contain sugar alcohols.

• Liver function tests (ALT, AST and total bilirubin).

• Subjects who are positive for the HLA-B*5701 allele.

• Subjects having Modified Patient Health Questionnaire (PHQ)-12 questionnaire score > 4.

• Subject has a creatinine clearance < 90 mL/min, as determined by the Cockroft-Gault equation.

• Any reason which, in the opinion of the Principal Investigator or Medical Sub- Investigator, would prevent the subject from safely participating in the study.

• Intolerance to venipuncture.

• Donation or loss of blood or plasma.

• Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.

• Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject's participation in this study.

• Allergy or hypersensitivity to abacavir, dolutegravir, lamivudine, other related products, or any inactive ingredients.