NCT01702675 - Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

June 30, 2017

Conditions

Healthy

Interventions

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)

Trial Locations (1)

ICF - Instituto de Ciências Farmacêuticas, Aparecida de Goiânia