ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

NCT02949089 | Completed Phase 1

• 1 other identifier: ACH-PSD-01(04/11)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety of rising multiple doses of ACH04

  Evaluate the occurrence of adverse events, Assess safety through laboratory tests and Assess safety through electrocardiogram

  up to 39 days

Study Arms (1)

ACH04

EXPERIMENTAL

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

Drug: ACH04

Interventions

ACH04 DRUG

The subjects will receive the study medication in each group

ACH04

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

UNIFAC

Fortaleza, Ceará, 60160140, Brazil

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: October 31, 2016
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

BR (1)