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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.

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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

FieldValue
Enrollment Target 33 participants
Start Date 2021-05-07
Est. Completion 2021-07-23
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.