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NCT04827134 · ClinicalTrials.gov registry record · Phase 1
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT04827134 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 33 participants.
The verdict
NCT04827134, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir \[DTG\] 5 milligrams \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants. Additionally, safety and tolerability of these formulations will also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of companies.
Interventions
- DRUG TRIUMEQ
- DRUG DOVATO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04827134
The ClinicalTrials.gov registry entry for NCT04827134 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 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 2 interventions - of which TRIUMEQ is the first listed.
NCT04827134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04827134 about?
NCT04827134 is a clinical study titled "A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants". This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir \[DTG\] 5 milligrams \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in healthy adult participants...
What is the current status of trial NCT04827134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2021-05-07. Estimated completion is 2021-07-23.
What interventions are being tested in trial NCT04827134?
The interventions under investigation include: TRIUMEQ (DRUG), DOVATO (DRUG).
Who is sponsoring clinical trial NCT04827134?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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