HIV-1-infectionEarly Phase 1NCT05030025

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

A Early Phase 1 study testing abacavir, dolutegravir and lamivudine dispersible tablets and Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine in people with HIV-1-infection, run by Mylan Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: HIV-1-infection
What is being tested?: abacavir, dolutegravir and lamivudine dispersible tablets and Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteCanada
Study dates: 1 Aug 2021to 29 Aug 2021
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Altasciences
Montreal, Quebec, H3P 3P1

Other trials in Canada

About this study

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

Read the 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.

Conditions: HIV-1-infection
Being tested: abacavir, dolutegravir and lamivudine dispersible tablets, Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

abacavir, dolutegravir and lamivudine dispersible tabletsCombination product
Also called fixed combination
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)
Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg LamivudineCombination product
Also called Triumeq
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)

Study groups in NCT05030025
Study group	Role	What they receive
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. Receives: 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. Receives: Combination Product: abacavir, dolutegravir and lamivudine dispersible tablets; Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 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
Measured: 2 weeks
Area under the plasma concentration versus time curve (AUC)0-∞
Area under the plasma concentration-time curve from zero to infinity
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202129 Aug 2021

First posted1 Sep 2021
Study start1 Aug 2021
Primary completion29 Aug 2021
Study completion29 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Single-dose, randomized, two-period, two-treatment, two-group, crossover study.
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05030025
Sponsor's protocol ID: ABDL-TBP-1001
Status last verified: Mar 2022
First submitted: 28 Jul 2021
Last updated: 25 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential
ClinicalTrials.gov ID: NCT05030025
Acronym / sponsor ID: ABDL-TBP-1001
Conditions: HIV-1-infection
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Collaborators: ViiV Healthcare
Study start: 1 Aug 2021 (actual)
Primary completion: 29 Aug 2021 (actual)
Study completion: 29 Aug 2021 (actual)
First posted: 1 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Single-dose, randomized, two-period, two-treatment, two-group, crossover study.

Arm	Type	Receives
Group 1	Experimental	Combination Product: abacavir, dolutegravir and lamivudine dispersible tablets, Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudinesingle-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fasting conditions.
Group 2	Experimental	Combination Product: abacavir, dolutegravir and lamivudine dispersible tablets, Combination Product: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudinesingle-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fed conditions.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
abacavir, dolutegravir and lamivudine dispersible tabletsAlso: fixed combinationAbacavir, 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)	Combination product	Group 1, Group 2
Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg LamivudineAlso: TriumeqTriumeq 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)	Combination product	Group 1, Group 2

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.

Related trials for HIV-1-infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
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RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tracey Lawrence, Ph.D. study director

Mylan Pharmaceuticals Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05030025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.