Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT02893488 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples will be collected at pre-dose and at specific post-dose time points for calculating AUC \[0- infinity\]
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 |
What the finished NCT02893488 record still lists
NCT02893488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which DTG/ABC/3TC FDC DISPERSIBLE TABLET is the first listed.
NCT02893488 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02893488's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI