Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug (ACH15)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Ache Laboratorios Farmaceuticos S.A.
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01702675
First received: September 26, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Safety
Pharmacokinetics
Tolerability
Healthy Men
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
Phase 1

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

Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Eletrocardiogram [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Echocardiography (participants included in Group 6) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cmax [ Time Frame: 31 time points up to 2 days ] [ Designated as safety issue: No ]
    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

  • High digestive endoscopy (participants included at Group 6) [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Image exam to evaluate the drug safety

  • Blood analysis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Blood will be colected to evatuate the drug safety by analysis of biochemical profile

  • Cmax [ Time Frame: 67 pint time over 8 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACH15 - 50mg capsule
ACH15 50mg capsule by mouth single dose (Group 1)
Drug: ACH15 50 mg
ACH15 50mg capsule
Experimental: ACH15 - 250 mg capsule
ACH15 250mg capsule by mouth as single dose(Group 2)
Drug: ACH15 250 mg
ACH15 250mg capsule
Experimental: ACH15 - 500mg capsule
ACH15 500mg capsule by mouth in a single dose(Group 3)
Drug: ACH15 500mg
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)
Drug: ACH15 - 1000mg
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)
Drug: ACH15 - 2000mg
ACH15 500mg capsule (four 500mg capsules in one dose)
Experimental: ACH15 - 500 mg (twice a day for 7 days)
ACH15 500mg capsule by mouthn twice a day for seven days (Group 6)
Drug: ACH15 - 500mg
ACH15 - 500mg twice a day for 7 days
Placebo Comparator: Placebo - 250 mg capsule
Placebo 250mg capsule by mouth single dose (Group 2)
Drug: Placebo 250 mg
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)
Drug: Placebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule
Drug: Placebo 500mg
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)
Drug: Placebo 1000mg
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)
Drug: Placebo 2000mg
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 mouthn twice a day for seven days (Group 7)
Drug: Placebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule
Drug: Placebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702675

Contacts
Contact: Ney Cartes do Carmo Borges, Doctor +55 19 3233 7300 medney@synchrophar.com

Locations
Brazil
Synchrophar Not yet recruiting
Campinas, São Paulo, Brazil, 13073-200
Contact: Ney Ney Carter do Carmo , Borges    +55 19 3233 7300      
Principal Investigator: Ney Carter do Carmo Borges, Doctor         
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
  More Information

No publications provided

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01702675     History of Changes
Other Study ID Numbers: ACH-HML-01(03/12)
Study First Received: September 26, 2012
Last Updated: October 5, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Safety
Pharmacokinetics
Tolerability
Healthy men

ClinicalTrials.gov processed this record on July 23, 2014