NCT01702675

Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug

Phase I, Monocentric, Double-blind, Randomized Study to Assess Tolerability, Safety and Pharmacokinetics of ACH15 After Single Dose and Multiple Doses in Healthy Male Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is evaluate the safety and tolerability parameters regarding the new drug in healthy men and evaluate the pharmacokinetics parameters after one dose and multiple doses of the new drug.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACH15 50 mg	ACH15 50mg capsule
DRUG	ACH15 250 mg	ACH15 250mg capsule
DRUG	ACH15 500mg	ACH15 500 mg capsule
DRUG	ACH15 - 1000mg	ACH15 500mg capsule - two 500mg capsules in single dose
DRUG	ACH15 - 2000mg	ACH15 500mg capsule (four 500mg capsules in one dose)
DRUG	ACH15 - 500mg	ACH15 - 500mg twice a day for 7 days
DRUG	Placebo 250 mg	Capsule manufactured to mimic ACH15 250 mg capsule
DRUG	Placebo 500mg	Capsule manufactured to mimic ACH15 500 mg capsule
DRUG	Placebo 1000mg	Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
DRUG	Placebo 2000mg	Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
DRUG	Placebo 500mg	Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2012-10-08
• Last updated: 2016-10-31

Locations

1 site across 1 country: Brazil