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

NCT05030025 | Completed Early Phase 1

• 1 other identifier: ABDL-TBP-1001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

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; Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

Group 2

EXPERIMENTAL

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; Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

Interventions

abacavir, dolutegravir and lamivudine dispersible tablets COMBINATION_PRODUCT

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)

Also known as: fixed combination

Group 1; Group 2

Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine COMBINATION_PRODUCT

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)

Also known as: Triumeq

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mylan Inc.: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Altasciences

Montreal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

abacavir; dolutegravir; Lamivudine; abacavir, dolutegravir, and lamivudine drug combination

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Tracey Lawrence, Ph.D.

  Mylan Pharmaceuticals Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-dose, randomized, two-period, two-treatment, two-group, crossover study.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 1, 2021
• Study Start: August 1, 2021
• Primary Completion: August 29, 2021
• Study Completion: August 29, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Locations

CA (1)