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
Overview
- Phase
- Phase 1
- Intervention
- ACH15 500mg
- Conditions
- Healthy
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
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;
Arms & Interventions
ACH15 - 500mg capsule
ACH15 500mg capsule by mouth in a single dose(Group 3)
Intervention: ACH15 500mg
ACH15 - 50mg capsule
ACH15 50mg capsule by mouth single dose (Group 1)
Intervention: ACH15 50 mg
ACH15 - 250 mg capsule
ACH15 250mg capsule by mouth as single dose(Group 2)
Intervention: ACH15 250 mg
ACH15 - 1000 mg (two 500mg capsule)
ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
Intervention: ACH15 - 1000mg
ACH15 - 2000 mg (four 500 mg capsule)
ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
Intervention: ACH15 - 2000mg
ACH15 - 500 mg (twice a day for 7 days)
ACH15 500mg capsule by mouth twice a day for seven days (Group 6)
Intervention: ACH15 - 500mg
Placebo - 250 mg capsule
Placebo 250mg capsule by mouth single dose (Group 2)
Intervention: Placebo 250 mg
Placebo - 500 mg capsule
Placebo 500mg capsule by mouth in a single dose(Group 3)
Intervention: Placebo 500mg
Placebo - 1000 mg (two 500mg capsule)
Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
Intervention: Placebo 1000mg
Placebo 2000 mg (four 500mg capsule)
Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
Intervention: Placebo 2000mg
Placebo - 500 mg (twice a day for 7 days)
Placebo 500mg capsule by mouth twice a day for seven days (Group 7)
Intervention: Placebo 500mg
Outcomes
Primary Outcomes
Cmax
Time Frame: 67 pint time over 8 days
Blood analysis to evaluate drug pharmacokinetics at Group 6:00:30 min before dose, 00h20min, 00h40min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06h, 08h, 10h, 12h, 14h, 18h, 24h, 26h, 30h, 36h, 38h, 42h, 48h, 50h, 54h, 60h, 62h, 66h, 72h, 74h, 78h, 84h, 86h, 90h, 96h, 98h, 102h, 108h, 110h, 114h, 120h, 122h, 126h, 132h, 134h, 138h, 144h, 146h, 150h, 156h, 158h, 162h, 168h, 174h, 180h e 192h post-dose.
High digestive endoscopy (participants included at Group 6)
Time Frame: 8 days
Image exam to evaluate the drug safety
Echocardiography (participants included in Group 6)
Time Frame: 30 days
Blood pressure
Time Frame: 30 days
Electrocardiogram
Time Frame: 30 days
Blood analysis
Time Frame: 30 days
Blood will be collected to evaluate the drug safety by analysis of biochemical profile