# Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects

> **NCT01954615** · PHASE1 · COMPLETED · sponsor: **Idorsia Pharmaceuticals Ltd.** · enrollment: 49 (actual)

## Conditions studied

- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

## Interventions

- **DRUG:** 5 mg ACT-281959 prodrug formulation I (Group A)
- **DRUG:** 20 mg ACT-281959 prodrug formulation I (Group B)
- **DRUG:** ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
- **DRUG:** ACT-281959 prodrug formulation II (Group G dose to be defined)
- **DRUG:** ACT-246475 (Group G dose to be defined)
- **DRUG:** Placebo (Groups A to F)

## Key facts

- **NCT ID:** NCT01954615
- **Lead sponsor:** Idorsia Pharmaceuticals Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-10
- **Primary completion:** 2012-03
- **Final completion:** 2012-03
- **Target enrollment:** 49 (ACTUAL)
- **Last updated:** 2018-07-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01954615

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01954615, "Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01954615. Licensed CC0.

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