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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: Completed Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PK parameters include area under the concentration-time curve from time zero extrapolated to infinite time (AUC \[0-infinity\]) Maximum observed concentration (Cmax) and apparent oral clearance (CL/F)
Conditions Studied
Interventions
- DRUG Dolutegravir Pediatric Granules
- DRUG Dolutegravir Dispersible Tablet
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT02185300 record still lists
NCT02185300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 147-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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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Where NCT02185300's enrollment target sits among peer trials
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