NCT02186002

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)

Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose, With Nested Cross-over for Food Effect, to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-451840 in Healthy Subjects (Part A)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study was to evaluate the safety and tolerability of ACT-451840 in healthy male subjects.Secondary objectives were : to investigate the pharmacokinetics (PK) of ACT-451840; to investigate the effect of food on the PK of ACT-451840; to evaluate the urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-451840 10 mg	ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
DRUG	ACT-451840 50 mg	ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
DRUG	ACT-451840 200 mg	ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
DRUG	ACT-451840 500 mg	ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
DRUG	ACT-451840 1000 mg	ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
DRUG	ACT-451840 (Dose to be determined)	ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
DRUG	Placebo

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2014-07-10
• Last updated: 2019-08-09

Locations

1 site across 1 country: France