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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: ACH15 50 mg; Drug: ACH15 250 mg; Drug: ACH15 500mg; Drug: ACH15 - 1000mg; Drug: ACH15 - 2000mg; Drug: Placebo 2000mg; Drug: ACH15 - 500mg; Drug: Placebo 250 mg; Drug: Placebo 500mg; Drug: Placebo 1000mg

• Registration Number: NCT01702675
• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-26
• Study First Submitted QC: 2012-10-05
• Study First Posted: 2012-10-08
• Study Start: 2015-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31
• Primary Completion: 2017-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 22

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACH15 - 50mg capsule	ACH15 50 mg	ACH15 50mg capsule by mouth single dose (Group 1)
ACH15 - 250 mg capsule	ACH15 250 mg	ACH15 250mg capsule by mouth as single dose(Group 2)
ACH15 - 500mg capsule	ACH15 500mg	ACH15 500mg capsule by mouth in a single dose(Group 3)
ACH15 - 1000 mg (two 500mg capsule)	ACH15 - 1000mg	ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
ACH15 - 2000 mg (four 500 mg capsule)	ACH15 - 2000mg	ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
Placebo 2000 mg (four 500mg capsule)	Placebo 2000mg	Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
ACH15 - 500 mg (twice a day for 7 days)	ACH15 - 500mg	ACH15 500mg capsule by mouth twice a day for seven days (Group 6)
Placebo - 250 mg capsule	Placebo 250 mg	Placebo 250mg capsule by mouth single dose (Group 2)
Placebo - 500 mg capsule	Placebo 500mg	Placebo 500mg capsule by mouth in a single dose(Group 3)
Placebo - 1000 mg (two 500mg capsule)	Placebo 1000mg	Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
Placebo - 500 mg (twice a day for 7 days)	Placebo 500mg	Placebo 500mg capsule by mouth twice a day for seven days (Group 7)

Primary Outcome Measures

Name	Time	Method
Cmax	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)	8 days	Image exam to evaluate the drug safety
Echocardiography (participants included in Group 6)	30 days
Blood pressure	30 days
Electrocardiogram	30 days
Blood analysis	30 days	Blood will be collected to evaluate the drug safety by analysis of biochemical profile

Trial Locations

Locations (1)

ICF - Instituto de Ciências Farmacêuticas; 🇧🇷 Aparecida de Goiânia, Goiás, Brazil