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NCT02475135
Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination
Phase 1 trial testing Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC in Healthy in 72 participants. Completed in 14 August 2015.
14 August 2015
Quick facts
| Lead sponsor | Janssen Sciences Ireland UC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 June 2015 |
| Primary completion | 14 August 2015 |
| Estimated completion | 14 August 2015 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC — full drug profile →
- Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC — full drug profile →
- Darunavir (DARUNAVIR) — full drug profile →
- Emtricitabine/Tenofovir alafenamide (FTC/TAF) — full drug profile →
- Cobicistat (COBICISTAT) — full drug profile →
- High-fat Breakfast
- Standardized Regular Breakfast
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Janssen Sciences Ireland UC — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of Emtricitabine (FTC) and Tenofovir alafenamide (TAF) when administered as a fixed-dose combination (FDC) with darunavir (DRV) and cobicistat (COBI) (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) relative to administration as an FDC with Elvitegravir (EVG) and COBI (Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), under fed conditions in healthy subjects (Panel 1); evaluate the single-dose pharmacokinetics and relative bioavailability of DRV, COBI, FTC and TAF when administered as an FDC (D/C/F/TAF) or as separate agents (D+C+FTC/TAF), under fed conditions in healthy subjects (Panel 2) and to evaluate the impact of food (fasting or high-fat breakfast) on the single-dose pharmacokinetics of DRV, COBI, FTC, and TAF when administered as an FDC (D/C/F/TAF) in healthy subjects (Panel 3).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Darunavir-cobicistat-emtricitabine-tenofovir alafenamide: safety and efficacy of a protease inhibitor in the modern era.
Squillace N, Bozzi G, Colella E, Gori A, et al · · 2018 · cited 11× · PMID 30464395 · DOI 10.2147/dddt.s147493 -
Bioequivalence of the Once-Daily Single-Tablet Regimen of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Compared to Combined Intake of the Separate Agents and the Effect of Food on Bioavailability.
Crauwels HM, Baugh B, Van Landuyt E, Vanveggel S, et al · · 2019 · cited 5× · PMID 30412360 · DOI 10.1002/cpdd.628 -
International Congress of Drug Therapy in HIV Infection 23-26 October 2016, Glasgow, UK.
· 2016 · cited 3× · PMID 27780519 · DOI 10.7448/ias.19.8.21487
Verify or expand the search:
- PubMed search for NCT02475135
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Janssen Sciences Ireland UC trials
Trials by the same sponsor.
- NCT04208399 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379 · Phase 1 · completed
- NCT04208386 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989 · Phase 1 · completed
- NCT04056611 — Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who A · Phase 2 · terminated
- NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virolo · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02475135 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Sciences Ireland UC
- Last refreshed: 17 October 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02475135.
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