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NCT03095638 · ClinicalTrials.gov registry record · Phase 1
Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT03095638 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 38 participants.
The verdict
NCT03095638, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The aim of this cross-over study is to compare the relative bioavailability and pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be carried out in 2 parts. Part 1 of the study will be open-label, 2 period designs with a wash out period of at least 7 days between the dosing periods. Subjects will be randomized to receive either single dose of five 10 mg DTG tablets or one 50 mg DTG tablet in a crossover manner in the fasting state. Part 2 of the study will be a 3 period crossover design with a wash out period of at least 7 days between the dosing periods. Subjects will be randomized to receive either single dose of five 5 mg DTG tablets (administered as dispersed with water or directly to mouth) or one 25 mg DTG tablet in a crossover manner in the fasting state. Subjects will have a follow-up visit 7-10 days post last dose of study treatment. Approximately 14 healthy subjects will participate in Part 1 and approximately 24 healthy subjects will participate in Part 2 of the study. The total duration of Part 1 will be approximately 7 to 8 weeks and that of part 2 will be approximately 8 to 9 weeks. TIVICAY® is a trademark of the GlaxoSmithKline group of companies.
Interventions
- DRUG Conventional dolutegravir 10 mg tablet
- DRUG Conventional dolutegravir 50 mg tablet
- DRUG Dispersible dolutegravir 5 mg tablet
- DRUG Conventional dolutegravir 25 mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2017-05-03 |
| Est. Completion | 2017-06-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095638
The ClinicalTrials.gov registry entry for NCT03095638 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 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 4 interventions - of which Conventional dolutegravir 10 mg tablet is the first listed.
NCT03095638 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03095638 about?
NCT03095638 is a clinical study titled "Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir". The aim of this cross-over study is to compare the relative bioavailability and pharmacokinetic parameters of both 10 mg conventional tablets and 5 mg dispersible tablets of dolutegravir (DTG) with that of 25 mg or 50 mg conventional DTG tablets. The study will be carried out in 2 parts. Part 1 of t...
What is the current status of trial NCT03095638?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2017-05-03. Estimated completion is 2017-06-23.
What interventions are being tested in trial NCT03095638?
The interventions under investigation include: Conventional dolutegravir 10 mg tablet (DRUG), Conventional dolutegravir 50 mg tablet (DRUG), Dispersible dolutegravir 5 mg tablet (DRUG), Conventional dolutegravir 25 mg tablet (DRUG).
Who is sponsoring clinical trial NCT03095638?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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