- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702675
Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug (ACH15)
October 27, 2016 updated by: Ache Laboratorios Farmaceuticos S.A.
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
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Goiás
-
Aparecida de Goiânia, Goiás, Brazil, 74935-530
- ICF - Instituto de Ciências Farmacêuticas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACH15 - 50mg capsule
ACH15 50mg capsule by mouth single dose (Group 1)
|
ACH15 50mg capsule
|
Experimental: ACH15 - 250 mg capsule
ACH15 250mg capsule by mouth as single dose(Group 2)
|
ACH15 250mg capsule
|
Experimental: ACH15 - 500mg capsule
ACH15 500mg capsule by mouth in a single dose(Group 3)
|
ACH15 500 mg capsule
|
Experimental: ACH15 - 1000 mg (two 500mg capsule)
ACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
|
ACH15 500mg capsule - two 500mg capsules in single dose
|
Experimental: ACH15 - 2000 mg (four 500 mg capsule)
ACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
|
ACH15 500mg capsule (four 500mg capsules in one dose)
|
Experimental: ACH15 - 500 mg (twice a day for 7 days)
ACH15 500mg capsule by mouth twice a day for seven days (Group 6)
|
ACH15 - 500mg twice a day for 7 days
|
Placebo Comparator: Placebo - 250 mg capsule
Placebo 250mg capsule by mouth single dose (Group 2)
|
Capsule manufactured to mimic ACH15 250 mg capsule
|
Placebo Comparator: Placebo - 500 mg capsule
Placebo 500mg capsule by mouth in a single dose(Group 3)
|
Capsule manufactured to mimic ACH15 500 mg capsule
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)
|
Placebo Comparator: Placebo - 1000 mg (two 500mg capsule)
Placebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4)
|
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
|
Placebo Comparator: Placebo 2000 mg (four 500mg capsule)
Placebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5)
|
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
|
Placebo Comparator: Placebo - 500 mg (twice a day for 7 days)
Placebo 500mg capsule by mouth twice a day for seven days (Group 7)
|
Capsule manufactured to mimic ACH15 500 mg capsule
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 30 days
|
30 days
|
|
Electrocardiogram
Time Frame: 30 days
|
30 days
|
|
Echocardiography (participants included in Group 6)
Time Frame: 30 days
|
30 days
|
|
Cmax
Time Frame: 31 time points up to 2 days
|
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)
Time Frame: 8 days
|
Image exam to evaluate the drug safety
|
8 days
|
Blood analysis
Time Frame: 30 days
|
Blood will be collected to evaluate the drug safety by analysis of biochemical profile
|
30 days
|
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.
|
67 pint time over 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sérgio Vencio, MD, ICF - Instituto de Ciências Farmacêuticas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
September 26, 2012
First Submitted That Met QC Criteria
October 5, 2012
First Posted (Estimate)
October 8, 2012
Study Record Updates
Last Update Posted (Estimate)
October 31, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ACH-HML-01(03/12)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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