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NCT03078556 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT03078556: Completed Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT03078556 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 154 participants, above the 139-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (11% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078556, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 periods design with a wash out period of at least 7 days between treatment periods. Subjects will be randomized to receive either single entities or formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16 subjects who complete the first two treatment periods and consent to continue will receive a single dose of FDC formulation 1 tablet administered with a high fat meal for a third treatment period. In Part 2 of the study, subjects will be randomized to receive either single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods. Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the study and if Part 2 of the study is conducted, another 76 healthy subjects will be included. The total duration will be approximately 11 weeks.
Primary Outcome
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Par
Conditions Studied
Interventions
- DRUG Dolutegravir
- DRUG Lamivudine
- DRUG Dolutegravir + Lamivudine FDC Formulation 1
- DRUG Dolutegravir + Lamivudine FDC Formulation 2
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2017-03-27 |
| Est. Completion | 2017-08-18 |
| Phase | Phase 1 |
What the finished NCT03078556 record still lists
NCT03078556 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 139-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (11% higher).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 4 interventions - of which Dolutegravir is the first listed.
NCT03078556 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT03078556 about?
NCT03078556 is a clinical study titled "Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine". This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 perio...
What is the current status of trial NCT03078556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2017-03-27. Estimated completion is 2017-08-18.
What conditions does trial NCT03078556 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT03078556?
The interventions under investigation include: Dolutegravir (DRUG), Lamivudine (DRUG), Dolutegravir + Lamivudine FDC Formulation 1 (DRUG), Dolutegravir + Lamivudine FDC Formulation 2 (DRUG).
Who is sponsoring clinical trial NCT03078556?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03078556 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03078556's enrollment target sits among peer trials
154 5th of 19 higher than 15 of 19 other Infection, Human Immunodeficiency Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection, Human Immunodeficiency Virus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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