Clinical trial NCT01702675: Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug
Official title: Phase I, Monocentric, Double-blind, Randomized Study to Assess Tolerability, Safety and Pharmacokinetics of ACH15 After Single Dose and Multiple Doses in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Pharmacokinetics
Tolerability
Healthy men
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male patient, aged between 18 and 50 years;
* Body weight ≥ 50 kg and BMI ≥ 18.5 kg/m2 and ≤ 30 kg/m2;
* Healthy men accordance with their historical and tests;
* Healthy subject with laboratory results within the normal range or within the parameters accepted by the clinical protocol
* Negative results for parasitological stool examination performed in the clinical study;
* Subject of research with laboratory results within the normal range for urinalysis collected before the first visit;
* Research subjects allocated in Group 6 with endoscopy within the normal range;

Exclusion Criteria:

* History of gastrointestinal disease, hepatic, renal, cardiovascular, pulmonary, neurologic, hematologic, diabetes or glaucoma;
* Evidence on clinical examination or physical or complement, organ dysfunction or any clinically significant deviation from normality;
* History of use of psychotropic drugs or excessive alcohol consumption (more than two units of alcohol per day, one unit being equivalent to one cup (200 mL) of brew or a dose (50) mL of distilled beverage) or having difficulty to abstain during the study;
* Use of any medication two (2) weeks prior to inclusion of the research subject in the study;
* Regular smokers or who quit less than one (1) year;
* History of food allergy or hyperreactivity to medications or foods;
* HIV positive for HIV;
* Being positive for Hepatitis B;
* Being positive for hepatitis C;
* Testing positive for Helicobacter pilorum;
* Using substances modulating hepatic microsomal activity within thirty (30) days prior to entry of the subject of research in the clinical study (date of signing the consent form);
* Having donated blood (blood volume higher than 500 mL) within four (4) months preceding the date of signing the consent form;
* Subject with a history of hypersensitivity to any component of the investigational product;

Primary outcomes:
measure: Blood pressure
timeFrame: 30 days
measure: Electrocardiogram
timeFrame: 30 days
measure: Echocardiography (participants included in Group 6)
timeFrame: 30 days
measure: Cmax
timeFrame: 31 time points up to 2 days
measure: High digestive endoscopy (participants included at Group 6)
timeFrame: 8 days
measure: Blood analysis
timeFrame: 30 days
measure: Cmax
timeFrame: 67 pint time over 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aparecida de Goiânia
country: Brazil
facility: ICF - Instituto de Ciências Farmacêuticas
state: Goiás
Study officials:
affiliation: ICF - Instituto de Ciências Farmacêuticas
name: Sérgio Vencio, MD
role: PRINCIPAL_INVESTIGATOR
References: