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NCT02185300 · ClinicalTrials.gov registry record · Phase 1

Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers

A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT02185300 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 15 participants, below the 147-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02185300, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada, Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative to the granule formulation, already in development, and the approved film-coated tablet. This is a single-center, randomized, open-label, 5-way crossover study in healthy adult subjects. The study will evaluate the relative bioavailability of five dosing regimens: 20 mg DTG pediatric granules (Treatment A) and of DTG 20 mg dispersible tablets (DTG 20 mg DT) after dispersed in: low mineral content(LMC) water (Treatment B); dispersed in CONTREX™ mineral water (Treatment C); dispersed in low mineral content water and consumed after standing for 30 minutes (Treatment D) and dispersed in CONTREX mineral water and consumed after standing for 30 minutes (Treatment E). Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug. CONTREX is a trademark of Nestlé Waters Corporation.

Conditions Studied

Infection, Human Immunodeficiency Virus

Interventions

  • DRUG Dolutegravir Pediatric Granules
  • DRUG Dolutegravir Dispersible Tablet

Study Locations (1)

Kansas

  • GSK Investigational Site - Overland Park

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-07
Est. Completion 2014-09
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

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What the Registry Record Tells You About NCT02185300

The ClinicalTrials.gov registry entry for NCT02185300 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 147-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (90% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 2 interventions - of which Dolutegravir Pediatric Granules is the first listed.

NCT02185300 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.

Frequently Asked Questions

What is clinical trial NCT02185300 about?

NCT02185300 is a clinical study titled "Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers". Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada, Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative to the granule formulation, already in development, and the approved film-coated tablet. This is a single-center, ra...

What is the current status of trial NCT02185300?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-07. Estimated completion is 2014-09.

What conditions does trial NCT02185300 study?

This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.

What interventions are being tested in trial NCT02185300?

The interventions under investigation include: Dolutegravir Pediatric Granules (DRUG), Dolutegravir Dispersible Tablet (DRUG).

Who is sponsoring clinical trial NCT02185300?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02185300 being conducted?

This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.