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

Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection
• Intervention / Treatment: Combination product: abacavir, dolutegravir and lamivudine dispersible tablets; Combination product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

Detailed Description

This study is to investigate the bioequivalence of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets, 60 mg/5 mg/30 mg to ViiV's Triumeq Dispersible Tablets (5 mg GSK1349572 [dolutegravir]/ 60 mg abacavir/ 30 mg lamivudine) following administration of a single, oral 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg) dose of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets or ViiV's Triumeq Dispersible Tablets administered under fasting and fed conditions.

Adverse events will be monitored to ensure the safety and well-being of the healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3P 3P1
      • Altasciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fasting conditions.	Combination product: abacavir, dolutegravir and lamivudine dispersible tablets; Abacavir, Dolutegravir and Lamivudine Dispersible Tablets, 60 mg/5 mg/30 mg Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg); Other Names: fixed combination; Combination product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine; Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg); Other Names: Triumeq
Experimental: Group 2; single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fed conditions.	Combination product: abacavir, dolutegravir and lamivudine dispersible tablets; Abacavir, Dolutegravir and Lamivudine Dispersible Tablets, 60 mg/5 mg/30 mg Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg); Other Names: fixed combination; Combination product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine; Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine Dose: 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg); Other Names: Triumeq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	2 weeks
Area under the plasma concentration versus time curve (AUC) 0-t	Plasma concentration-time curve from zero to the time of the last measurable time point t	2 weeks
Area under the plasma concentration versus time curve (AUC)0-∞	Area under the plasma concentration-time curve from zero to infinity	2 weeks

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: ViiV Healthcare
• Investigators: Study Director: Tracey Lawrence, Ph.D., Mylan Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): August 29, 2021
• Study Completion (Actual): August 29, 2021

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; HIV Integrase Inhibitors; Integrase Inhibitors; Lamivudine; Dolutegravir; Abacavir; Dideoxynucleosides; Triumeq
• Other Study ID Numbers: ABDL-TBP-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No