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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 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.

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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.

Conditions Studied

Healthy

Interventions

  • DRUG Darunavir (DRV)
  • DRUG Cobicistat (COBI)
  • DRUG Emtricitabine (FTC)
  • DRUG Tenofovir Alafenamide (TAF)

Study Locations (1)

Arizona

  • - Tempe

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2016-12
Est. Completion 2017-02
Phase Phase 1

Sponsor

Janssen Scientific Affairs

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02984852

The ClinicalTrials.gov registry entry for NCT02984852 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.

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

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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.