# A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)

> **NCT02381496** · PHASE1 · COMPLETED · sponsor: **Idorsia Pharmaceuticals Ltd.** · enrollment: 88 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** ACT-453859 1 mg
- **DRUG:** ACT-453859 3 mg
- **DRUG:** ACT-453859 10 mg
- **DRUG:** ACT-453859 30mg
- **DRUG:** ACT-453859 100 mg
- **DRUG:** ACT-453859 300 mg
- **DRUG:** ACT-453859 800 mg
- **OTHER:** Placebo
- **DRUG:** Setipiprant 500 mg
- **DRUG:** Setipiprant 1000 mg

## Key facts

- **NCT ID:** NCT02381496
- **Lead sponsor:** Idorsia Pharmaceuticals Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-12
- **Primary completion:** 2012-04
- **Final completion:** 2012-04
- **Target enrollment:** 88 (ACTUAL)
- **Last updated:** 2018-07-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02381496

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02381496, "A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT02381496. Licensed CC0.

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