ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Drug: ACH04

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60160140
      • UNIFAC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACH04; Dosage: 1 capsule, PO, 24/24h for 10 days.	Drug: ACH04; The subjects will receive the study medication in each group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ache Laboratorios Farmaceuticos S.A.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 3, 2011
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: adult; tolerability; safety; male; rising multiple doses; ACH04
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: ACH-PSD-01(04/11)