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NCT02893488 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT02893488 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 20 participants.
The verdict
NCT02893488, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™ (\[abacavir, ABC\]/\[dolutegravir, DTG\]/\[lamivudine, 3TC\]) when dispersed and consumed under four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) + EPZICOM™ (ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately 20 subjects will be randomized, each to one of 5 treatment groups. The total duration of participation of a subject in this study will be approximately 10-11 weeks. It will include a screening visit within 30 days prior to the first dose of study drug, five treatment periods each with a single dose of study drug per treatment period and a follow up visit within 7 10 days after the last dose. There will also be a washout of at least 7 days between doses in each treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the GlaxoSmithKline group of companies.
Interventions
- DRUG DTG/ABC/3TC FDC DISPERSIBLE TABLET
- DRUG EPZICOM (ABC/3TC)
- DRUG TIVICAY (DTG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2016-11-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02893488
The ClinicalTrials.gov registry entry for NCT02893488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which DTG/ABC/3TC FDC DISPERSIBLE TABLET is the first listed.
NCT02893488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02893488 about?
NCT02893488 is a clinical study titled "Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet". This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™ (\[abacavir, ABC\]/\[dolutegr...
What is the current status of trial NCT02893488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2016-09-01. Estimated completion is 2016-11-25.
What interventions are being tested in trial NCT02893488?
The interventions under investigation include: DTG/ABC/3TC FDC DISPERSIBLE TABLET (DRUG), EPZICOM (ABC/3TC) (DRUG), TIVICAY (DTG) (DRUG).
Who is sponsoring clinical trial NCT02893488?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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