ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

NCT ID: NCT02949089

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-09-30

Brief Summary

This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.

Conditions

Diarrhea

Keywords

safety; tolerability; rising multiple doses; ACH04; adult; male

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACH04

Dosage: 1 capsule, PO, 24/24h for 10 days.

Group Type: EXPERIMENTAL

ACH04

Intervention Type: DRUG

The subjects will receive the study medication in each group

Interventions

ACH04

The subjects will receive the study medication in each group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects will be healthy males subjects between 18 and 50 years of age;
• Subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations;
• Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions.

Exclusion Criteria

• Subjects with hypersensitivity known to Psidium guajava L. or history of serious adverse events;
• Subjects who have a significant history of alcoholism or drug/chemical abuse;
• Subjects who have body mass index < 18 or > 30;
• Subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start;
• Subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive;
• Subjects who were hospitalized for any reason in the six week prior the study start;
• Subjects who, in the opinion of the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol;
• Subjects who are participating in a clinical trial or have participated in a clinical study involving administration of an investigational drug, within one year;
• Subjects who are relatives of employees from the sponsor and the site, respectively;
• Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator;
• Any finding of clinical observation (anamnesis and physical evaluation), laboratory abnormality, who in the investigator opinion, may jeopardize the subjects or interfere with the study goals.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UNIFAC

Fortaleza, Ceará, Brazil

Countries

Brazil

Other Identifiers

ACH-PSD-01(04/11)

Identifier Type: -

Identifier Source: org_study_id