# PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir

> **NCT00838760** · PHASE1 · COMPLETED · sponsor: **Tibotec Pharmaceuticals, Ireland** · enrollment: 54 (actual)

## Conditions studied

- HIV-1

## Interventions

- **DRUG:** TMC558445; TMC310911; Darunavir; Placebo

## Key facts

- **NCT ID:** NCT00838760
- **Lead sponsor:** Tibotec Pharmaceuticals, Ireland
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-02
- **Primary completion:** 2009-10
- **Final completion:** 2009-10
- **Target enrollment:** 54 (ACTUAL)
- **Last updated:** 2010-04-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00838760

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00838760, "PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT00838760. Licensed CC0.

---

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