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

NCT01702675 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-10-31

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Sérgio Vencio, MD · ICF - Instituto de Ciências Farmacêuticas

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-04-30
Completion
2017-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702675 on ClinicalTrials.gov