Clinical trial NCT05030025: Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)
Official title: Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: HIV-1-infection
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2021-09-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-dose, randomized, two-period, two-treatment, two-group, crossover study.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 2 weeks
measure: Area under the plasma concentration versus time curve (AUC) 0-t
timeFrame: 2 weeks
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Altasciences
state: Quebec
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Tracey Lawrence, Ph.D.
role: STUDY_DIRECTOR
References: