# A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

> **NCT04236453** · PHASE1 · TERMINATED · sponsor: **Janssen Pharmaceutica N.V., Belgium** · enrollment: 16 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC
- **DRUG:** Darunavir
- **DRUG:** Emtricitabine/Tenofovir Alafenamide
- **DRUG:** Cobicistat

## Key facts

- **NCT ID:** NCT04236453
- **Lead sponsor:** Janssen Pharmaceutica N.V., Belgium
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-01-23
- **Primary completion:** 2020-04-10
- **Final completion:** 2020-04-10
- **Target enrollment:** 16 (ACTUAL)
- **Why stopped:** COVID-19 pandemic impacted the BE assessment of the trial. The clinical team decided to terminate the trial in order to start a new pivotal BE trial
- **Last updated:** 2020-07-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04236453

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04236453, "A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04236453. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*