Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug (ACH15)

Ache Laboratorios Farmaceuticos

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo 250 mg; Drug: ACH15 50 mg; Drug: ACH15 - 2000mg; Drug: Placebo 2000mg; Drug: ACH15 250 mg; Drug: Placebo 1000mg; Drug: ACH15 - 500mg; Drug: ACH15 - 1000mg; Drug: Placebo 500mg; Drug: ACH15 500mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01702675

ACH-HML-01(03/12)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

22 participants in 11 patient groups, including a placebo group

ACH15 - 50mg capsule

Experimental group

Description:

ACH15 50mg capsule by mouth single dose (Group 1)

Treatment:

Drug: ACH15 50 mg

ACH15 - 250 mg capsule

Experimental group

Description:

ACH15 250mg capsule by mouth as single dose(Group 2)

Treatment:

Drug: ACH15 250 mg

ACH15 - 500mg capsule

Experimental group

Description:

ACH15 500mg capsule by mouth in a single dose(Group 3)

Treatment:

Drug: ACH15 500mg

ACH15 - 1000 mg (two 500mg capsule)

Experimental group

Description:

ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)

Treatment:

Drug: ACH15 - 1000mg

ACH15 - 2000 mg (four 500 mg capsule)

Experimental group

Description:

ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)

Treatment:

Drug: ACH15 - 2000mg

ACH15 - 500 mg (twice a day for 7 days)

Experimental group

Description:

ACH15 500mg capsule by mouth twice a day for seven days (Group 6)

Treatment:

Drug: ACH15 - 500mg

Placebo - 250 mg capsule

Placebo Comparator group

Description:

Placebo 250mg capsule by mouth single dose (Group 2)

Treatment:

Drug: Placebo 250 mg

Placebo - 500 mg capsule

Placebo Comparator group

Description:

Placebo 500mg capsule by mouth in a single dose(Group 3)

Treatment:

Drug: Placebo 500mg

Drug: Placebo 500mg

Placebo - 1000 mg (two 500mg capsule)

Placebo Comparator group

Description:

Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)

Treatment:

Drug: Placebo 1000mg

Placebo 2000 mg (four 500mg capsule)

Placebo Comparator group

Description:

Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)

Treatment:

Drug: Placebo 2000mg

Placebo - 500 mg (twice a day for 7 days)

Placebo Comparator group

Description:

Placebo 500mg capsule by mouth twice a day for seven days (Group 7)

Treatment:

Drug: Placebo 500mg

Drug: Placebo 500mg