ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

Diarrhea Clinical Trial

Official title:

An Open Label, Dose Escalation Study of ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949089
• Other study ID #: ACH-PSD-01(04/11)
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2011
• Last updated: October 27, 2016
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• ACH04
The subjects will receive the study medication in each group

Locations

Country	Name	City	State
Brazil	UNIFAC	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes