MedDataX Logo

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

NCT ID: NCT01702675

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Safety Pharmacokinetics Tolerability Healthy men

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACH15 - 50mg capsule

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

Group Type EXPERIMENTAL

ACH15 50 mg

Intervention Type DRUG

ACH15 50mg capsule

ACH15 - 250 mg capsule

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

Group Type EXPERIMENTAL

ACH15 250 mg

Intervention Type DRUG

ACH15 250mg capsule

ACH15 - 500mg capsule

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

Group Type EXPERIMENTAL

ACH15 500mg

Intervention Type DRUG

ACH15 500 mg capsule

ACH15 - 1000 mg (two 500mg capsule)

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

Group Type EXPERIMENTAL

ACH15 - 1000mg

Intervention Type DRUG

ACH15 500mg capsule - two 500mg capsules in single dose

ACH15 - 2000 mg (four 500 mg capsule)

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

Group Type EXPERIMENTAL

ACH15 - 2000mg

Intervention Type DRUG

ACH15 500mg capsule (four 500mg capsules in one dose)

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

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

Group Type EXPERIMENTAL

ACH15 - 500mg

Intervention Type DRUG

ACH15 - 500mg twice a day for 7 days

Placebo - 250 mg capsule

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

Group Type PLACEBO_COMPARATOR

Placebo 250 mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 250 mg capsule

Placebo - 500 mg capsule

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

Group Type PLACEBO_COMPARATOR

Placebo 500mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 500 mg capsule

Placebo 500mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

Placebo - 1000 mg (two 500mg capsule)

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

Group Type PLACEBO_COMPARATOR

Placebo 1000mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)

Placebo 2000 mg (four 500mg capsule)

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

Group Type PLACEBO_COMPARATOR

Placebo 2000mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)

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

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

Group Type PLACEBO_COMPARATOR

Placebo 500mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 500 mg capsule

Placebo 500mg

Intervention Type DRUG

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ACH15 50 mg

ACH15 50mg capsule

Intervention Type DRUG

ACH15 250 mg

ACH15 250mg capsule

Intervention Type DRUG

ACH15 500mg

ACH15 500 mg capsule

Intervention Type DRUG

ACH15 - 1000mg

ACH15 500mg capsule - two 500mg capsules in single dose

Intervention Type DRUG

ACH15 - 2000mg

ACH15 500mg capsule (four 500mg capsules in one dose)

Intervention Type DRUG

ACH15 - 500mg

ACH15 - 500mg twice a day for 7 days

Intervention Type DRUG

Placebo 250 mg

Capsule manufactured to mimic ACH15 250 mg capsule

Intervention Type DRUG

Placebo 500mg

Capsule manufactured to mimic ACH15 500 mg capsule

Intervention Type DRUG

Placebo 1000mg

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)

Intervention Type DRUG

Placebo 2000mg

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)

Intervention Type DRUG

Placebo 500mg

Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sérgio Vencio, MD

Role: PRINCIPAL_INVESTIGATOR

ICF - Instituto de Ciências Farmacêuticas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ICF - Instituto de Ciências Farmacêuticas

Aparecida de Goiânia, Goiás, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ACH-HML-01(03/12)

Identifier Type: -

Identifier Source: org_study_id