TerminatedNCT01702675ACH15Updated Oct 31, 2016

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

A Phase 1 interventional study of ACH15 50 mg and ACH15 250 mg in Healthy, sponsored by Ache Laboratorios Farmaceuticos S.A.. Terminated at 1 site in Brazil. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-31.

Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Male

Study 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 studied

Healthy

Keywords

Safety
Pharmacokinetics
Tolerability
Healthy men

In context

Lead sponsor

Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 34 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 22 participants (actual)

Study arms

Experimental
ACH15 - 50mg capsule
ACH15 50mg capsule by mouth single dose (Group 1)
Drug: ACH15 50 mg
Experimental
ACH15 - 250 mg capsule
ACH15 250mg capsule by mouth as single dose(Group 2)
Drug: ACH15 250 mg
Experimental
ACH15 - 500mg capsule
ACH15 500mg capsule by mouth in a single dose(Group 3)
Drug: ACH15 500mg
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
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
Experimental
ACH15 - 500 mg (twice a day for 7 days)
ACH15 500mg capsule by mouth twice a day for seven days (Group 6)
Drug: ACH15 - 500mg
Placebo comparator
Placebo - 250 mg capsule
Placebo 250mg capsule by mouth single dose (Group 2)
Drug: Placebo 250 mg
Placebo comparator
Placebo - 500 mg capsule
Placebo 500mg capsule by mouth in a single dose(Group 3)
Drug: Placebo 500mg
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
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
Placebo comparator
Placebo - 500 mg (twice a day for 7 days)
Placebo 500mg capsule by mouth twice a day for seven days (Group 7)
Drug: Placebo 500mg

Interventions

DrugACH15 50 mg
ACH15 50mg capsule
DrugACH15 250 mg
ACH15 250mg capsule
DrugACH15 500mg
ACH15 500 mg capsule
DrugACH15 - 1000mg
ACH15 500mg capsule - two 500mg capsules in single dose
DrugACH15 - 2000mg
ACH15 500mg capsule (four 500mg capsules in one dose)
DrugACH15 - 500mg
ACH15 - 500mg twice a day for 7 days
DrugPlacebo 250 mg
Capsule manufactured to mimic ACH15 250 mg capsule
DrugPlacebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule
DrugPlacebo 1000mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
DrugPlacebo 2000mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
DrugPlacebo 500mg
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)

What researchers measure

Primary outcomes

Blood pressure
Time frame: 30 days
Electrocardiogram
Time frame: 30 days
Echocardiography (participants included in Group 6)
Time frame: 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
Time frame: 31 time points up to 2 days
High digestive endoscopy (participants included at Group 6)
Image exam to evaluate the drug safety
Time frame: 8 days
Blood analysis
Blood will be collected to evaluate the drug safety by analysis of biochemical profile
Time frame: 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.
Time frame: 67 pint time over 8 days

Study locations

1 site

ICF - Instituto de Ciências Farmacêuticas
Aparecida de Goiânia, Goiás 74935-530, Brazil

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01702675
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Responsible party: Sponsor
First posted: Oct 8, 2012
Start date: May 2015
Primary completion: Apr 2017 (estimated)
Completion: Jun 2017 (estimated)
Last update: Oct 31, 2016

Study contacts

Sérgio Vencio, MD

principal investigator · ICF - Instituto de Ciências Farmacêuticas

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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