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NCT02984852 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants
A Phase 1 study of Healthy, sponsored by Janssen Scientific Affairs.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02984852: Completed Phase 1 study of Healthy, sponsored by Janssen Scientific Affairs.
NCT02984852 is a Phase 1 study of Healthy that has completed, run by Janssen Scientific Affairs. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02984852, a Phase 1 study of Healthy, has completed, sponsored by Janssen Scientific Affairs.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the single-dose pharmacokinetics and relative bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg, Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) tablet in healthy adult participants when given as Treatment A (reference): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet swallowed as a whole, intact tablet with 240milliliter (mL) of noncarbonated water.Treatment B (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a split tablet swallowed with 240 mL of noncarbonated water. Treatment C (test): a single dose of D/C/F/TAF (800/150/200/10 mg) FDC tablet as a crushed tablet mixed in 4 ounces (oz) of applesauce.
Primary Outcome
Cmax is defined as the maximum observed plasma concentration.
Conditions Studied
Interventions
- DRUG Darunavir (DRV)
- DRUG Cobicistat (COBI)
- DRUG Emtricitabine (FTC)
- DRUG Tenofovir Alafenamide (TAF)
Study Locations (1)
Arizona
- - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-02 |
| Phase | Phase 1 |
What the finished NCT02984852 record still lists
NCT02984852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which Darunavir (DRV) is the first listed.
NCT02984852 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT02984852 about?
NCT02984852 is a clinical study titled "Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants". The purpose of this study is to evaluate the single-dose pharmacokinetics and relative bioavailability of Darunavir (DRV) 800 milligram (mg), Cobicistat (COBI) 150 mg, Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC) (D/C/F/TAF) ta...
What is the current status of trial NCT02984852?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-12. Estimated completion is 2017-02.
What conditions does trial NCT02984852 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02984852?
The interventions under investigation include: Darunavir (DRV) (DRUG), Cobicistat (COBI) (DRUG), Emtricitabine (FTC) (DRUG), Tenofovir Alafenamide (TAF) (DRUG).
Who is sponsoring clinical trial NCT02984852?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02984852 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02984852's enrollment target sits among peer trials
30 678th of 1090 higher than 363 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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