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

Healthy Clinical Trial

— ACH15  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01702675
• Other study ID #: ACH-HML-01(03/12)
• Status: Terminated
• Phase: Phase 1
• First received: September 26, 2012
• Last updated: October 27, 2016
• Start date: May 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ACH15 50 mg
ACH15 50mg capsule
• ACH15 250 mg
ACH15 250mg capsule
• ACH15 500mg
ACH15 500 mg capsule
• ACH15 - 1000mg
ACH15 500mg capsule - two 500mg capsules in single dose
• ACH15 - 2000mg
ACH15 500mg capsule (four 500mg capsules in one dose)
• ACH15 - 500mg
ACH15 - 500mg twice a day for 7 days
• Placebo 250 mg
Capsule manufactured to mimic ACH15 250 mg capsule
• Placebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule
• Placebo 1000mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
• Placebo 2000mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
• Placebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

Locations

Country	Name	City	State
Brazil	ICF - Instituto de Ciências Farmacêuticas	Aparecida de Goiânia	Goiás

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		30 days	Yes
Primary	Electrocardiogram		30 days	Yes
Primary	Echocardiography (participants included in Group 6)		30 days	Yes
Primary	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	No
Primary	High digestive endoscopy (participants included at Group 6)	Image exam to evaluate the drug safety	8 days	Yes
Primary	Blood analysis	Blood will be collected to evaluate the drug safety by analysis of biochemical profile	30 days	Yes
Primary	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	No