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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ACH15 50 mg
* Drug: ACH15 250 mg
* Drug: ACH15 500mg
* Drug: ACH15 - 1000mg
* Drug: ACH15 - 2000mg
* Drug: ACH15 - 500mg
* Drug: Placebo 250 mg
* Drug: Placebo 500mg
* Drug: Placebo 1000mg
* Drug: Placebo 2000mg
* Drug: Placebo 500mg


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACH15 - 50mg capsule<br>ACH15 50mg capsule by mouth single dose (Group 1) | Drug: ACH15 50 mg<br>* ACH15 50mg capsule<br>|
| Experimental: ACH15 - 250 mg capsule<br>ACH15 250mg capsule by mouth as single dose(Group 2) | Drug: ACH15 250 mg<br>* ACH15 250mg capsule<br>|
| Experimental: ACH15 - 500mg capsule<br>ACH15 500mg capsule by mouth in a single dose(Group 3) | Drug: ACH15 500mg<br>* ACH15 500 mg capsule<br>|
| Experimental: ACH15 - 1000 mg (two 500mg capsule)<br>ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4) | Drug: ACH15 - 1000mg<br>* ACH15 500mg capsule - two 500mg capsules in single dose<br>|
| Experimental: ACH15 - 2000 mg (four 500 mg capsule)<br>ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5) | Drug: ACH15 - 2000mg<br>* ACH15 500mg capsule (four 500mg capsules in one dose)<br>|
| Experimental: ACH15 - 500 mg (twice a day for 7 days)<br>ACH15 500mg capsule by mouth twice a day for seven days (Group 6) | Drug: ACH15 - 500mg<br>* ACH15 - 500mg twice a day for 7 days<br>|
| Placebo Comparator: Placebo - 250 mg capsule<br>Placebo 250mg capsule by mouth single dose (Group 2) | Drug: Placebo 250 mg<br>* Capsule manufactured to mimic ACH15 250 mg capsule<br>|
| Placebo Comparator: Placebo - 500 mg capsule<br>Placebo 500mg capsule by mouth in a single dose(Group 3) | Drug: Placebo 500mg<br>* Capsule manufactured to mimic ACH15 500 mg capsule<br>Drug: Placebo 500mg<br>* Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)<br>|
| Placebo Comparator: Placebo - 1000 mg (two 500mg capsule)<br>Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4) | Drug: Placebo 1000mg<br>* Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)<br>|
| Placebo Comparator: Placebo 2000 mg (four 500mg capsule)<br>Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5) | Drug: Placebo 2000mg<br>* Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)<br>|
| Placebo Comparator: Placebo - 500 mg (twice a day for 7 days)<br>Placebo 500mg capsule by mouth twice a day for seven days (Group 7) | Drug: Placebo 500mg<br>* Capsule manufactured to mimic ACH15 500 mg capsule<br>Drug: Placebo 500mg<br>* Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 30 days | 
| Electrocardiogram |  | 30 days | 
| Echocardiography (participants included in Group 6) |  | 30 days | 
| Cmax | Blood analysis to evaluate drug pharmacokinetics at Group 1 to 5: 30 minutes and 05 minutes before dose and 00h10 min, 00h15 min, 00h30 min, 00h45 min, 01h, 01h15min, 01h30min, 01h45min, 02h, 02h15min, 02h30min, 02h45min, 03h, 03h15min, 03h30min, 03h45min, 04 h, 04h15min, 04h30min, 04h45min, 05h, 05h30min, 06 h, 08 h, 10 h, 12h, 16h, 24 h e 48hours post-dose | 31 time points up to 2 days | 
| High digestive endoscopy (participants included at Group 6) | Image exam to evaluate the drug safety | 8 days | 
| Blood analysis | Blood will be collected to evaluate the drug safety by analysis of biochemical profile | 30 days | 
| Cmax | 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. | 67 pint time over 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Pharmacokinetics, Tolerability, Healthy men