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

NCT01702675 | Terminated Phase 1 DMC

• 1 other identifier: ACH-HML-01(03/12)
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety; Pharmacokinetics; Tolerability; Healthy men

Outcome Measures

Primary Outcomes (7)

• Blood pressure

  30 days

• Electrocardiogram

  30 days

• Echocardiography (participants included in Group 6)

  30 days

• 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

• High digestive endoscopy (participants included at Group 6)

  Image exam to evaluate the drug safety

  8 days

• Blood analysis

  Blood will be collected to evaluate the drug safety by analysis of biochemical profile

  30 days

• 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

Study Arms (11)

ACH15 - 50mg capsule

EXPERIMENTAL

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

Drug: ACH15 50 mg

ACH15 - 250 mg capsule

EXPERIMENTAL

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

Drug: ACH15 250 mg

ACH15 - 500mg capsule

EXPERIMENTAL

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

Drug: ACH15 500mg

ACH15 - 1000 mg (two 500mg capsule)

EXPERIMENTAL

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

Drug: ACH15 - 1000mg

ACH15 - 2000 mg (four 500 mg capsule)

EXPERIMENTAL

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

Drug: ACH15 - 2000mg

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

EXPERIMENTAL

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

Drug: ACH15 - 500mg

Placebo - 250 mg capsule

PLACEBO COMPARATOR

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

Drug: Placebo 250 mg

Placebo - 500 mg capsule

PLACEBO COMPARATOR

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

Drug: Placebo 500mg

Placebo - 1000 mg (two 500mg capsule)

PLACEBO COMPARATOR

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

Drug: Placebo 1000mg

Placebo 2000 mg (four 500mg capsule)

PLACEBO COMPARATOR

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

Drug: Placebo 2000mg

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

PLACEBO COMPARATOR

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

Drug: Placebo 500mg

Interventions

ACH15 50 mg DRUG

ACH15 50mg capsule

ACH15 - 50mg capsule

ACH15 250 mg DRUG

ACH15 250mg capsule

ACH15 - 250 mg capsule

ACH15 - 500mg DRUG

ACH15 - 500mg twice a day for 7 days

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

ACH15 - 1000mg DRUG

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

ACH15 - 1000 mg (two 500mg capsule)

ACH15 - 2000mg DRUG

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

ACH15 - 2000 mg (four 500 mg capsule)

Placebo 250 mg DRUG

Capsule manufactured to mimic ACH15 250 mg capsule

Placebo - 250 mg capsule

Placebo 500mg DRUG

Capsule manufactured to mimic ACH15 500 mg capsule

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

Placebo 1000mg DRUG

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

Placebo - 1000 mg (two 500mg capsule)

Placebo 2000mg DRUG

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

Placebo 2000 mg (four 500mg capsule)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

ICF - Instituto de Ciências Farmacêuticas

Aparecida de Goiânia, Goiás, 74935-530, Brazil

Location

Study Officials

• Sérgio Vencio, MD

  ICF - Instituto de Ciências Farmacêuticas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 8, 2012
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 31, 2016

Record last verified: 2016-10

Locations

BR (1)