HealthyPhase 1ACH15NCT01702675
Study to Assess Tolerability, Safety and Pharmacokinetics of a New Drug
A Phase 1 study testing ACH15 50 mg, ACH15 250 mg and ACH15 500mg in people with Healthy, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACH15 50 mg, ACH15 250 mg and ACH15 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ICF - Instituto de Ciências Farmacêuticas
Aparecida de Goiânia, Goiás, 74935-530
About this study
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
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
- Being tested
- ACH15 50 mg, ACH15 250 mg, ACH15 500mg, ACH15 - 1000mg, ACH15 - 2000mg
- Keywords
- Safety, Pharmacokinetics, Tolerability, Healthy men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH15 50 mgDrug
ACH15 50mg capsule
ACH15 250 mgDrug
ACH15 250mg capsule
ACH15 500mgDrug
ACH15 500 mg capsule
ACH15 - 1000mgDrug
ACH15 500mg capsule - two 500mg capsules in single dose
ACH15 - 2000mgDrug
ACH15 500mg capsule (four 500mg capsules in one dose)
ACH15 - 500mgDrug
ACH15 - 500mg twice a day for 7 days
Placebo 250 mgDrug
Capsule manufactured to mimic ACH15 250 mg capsule
Placebo 500mgDrug
Capsule manufactured to mimic ACH15 500 mg capsule
Placebo 1000mgDrug
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
Placebo 2000mgDrug
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
Placebo 500mgDrug
Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)
| Study group | Role | What they receive |
|---|---|---|
| ACH15 - 50mg capsule | Experimental | ACH15 50mg capsule by mouth single dose (Group 1) Receives: Drug: ACH15 50 mg |
| ACH15 - 250 mg capsule | Experimental | ACH15 250mg capsule by mouth as single dose(Group 2) Receives: Drug: ACH15 250 mg |
| ACH15 - 500mg capsule | Experimental | ACH15 500mg capsule by mouth in a single dose(Group 3) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: ACH15 - 500mg |
| Placebo - 250 mg capsule | Placebo comparator | Placebo 250mg capsule by mouth single dose (Group 2) Receives: Drug: Placebo 250 mg |
| Placebo - 500 mg capsule | Placebo comparator | Placebo 500mg capsule by mouth in a single dose(Group 3) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Placebo 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 30 days
Electrocardiogram
Measured: 30 days
Echocardiography (participants included in Group 6)
Measured: 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
Measured: 31 time points up to 2 days
High digestive endoscopy (participants included at Group 6)
Image exam to evaluate the drug safety
Measured: 8 days
Blood analysis
Blood will be collected to evaluate the drug safety by analysis of biochemical profile
Measured: 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.
Measured: 67 pint time over 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startMay 2015
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sérgio Vencio, MD, Principal investigator, ICF - Instituto de Ciências Farmacêuticas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702675
- Sponsor's protocol ID
- ACH-HML-01(03/12)
- Acronym
- ACH15
- Status last verified
- Oct 2016
- First submitted
- 26 Sep 2012
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01702675
- Acronym / sponsor ID
- ACH15 / ACH-HML-01(03/12)
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics, Tolerability, Healthy men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| ACH15 - 50mg capsule | Experimental | Drug: ACH15 50 mgACH15 50mg capsule by mouth single dose (Group 1) |
| ACH15 - 250 mg capsule | Experimental | Drug: ACH15 250 mgACH15 250mg capsule by mouth as single dose(Group 2) |
| ACH15 - 500mg capsule | Experimental | Drug: ACH15 500mgACH15 500mg capsule by mouth in a single dose(Group 3) |
| ACH15 - 1000 mg (two 500mg capsule) | Experimental | Drug: ACH15 - 1000mgACH15 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4) |
| ACH15 - 2000 mg (four 500 mg capsule) | Experimental | Drug: ACH15 - 2000mgACH15 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5) |
| ACH15 - 500 mg (twice a day for 7 days) | Experimental | Drug: ACH15 - 500mgACH15 500mg capsule by mouth twice a day for seven days (Group 6) |
| Placebo - 250 mg capsule | Placebo comparator | Drug: Placebo 250 mgPlacebo 250mg capsule by mouth single dose (Group 2) |
| Placebo - 500 mg capsule | Placebo comparator | Drug: Placebo 500mgPlacebo 500mg capsule by mouth in a single dose(Group 3) |
| Placebo - 1000 mg (two 500mg capsule) | Placebo comparator | Drug: Placebo 1000mgPlacebo 500mg capsule by mouth, two 500 mg capsules once as a single dose(Group 4) |
| Placebo 2000 mg (four 500mg capsule) | Placebo comparator | Drug: Placebo 2000mgPlacebo 500mg capsule by mouth, four 500 mg capsules once as a single dose(Group 5) |
| Placebo - 500 mg (twice a day for 7 days) | Placebo comparator | Drug: Placebo 500mgPlacebo 500mg capsule by mouth twice a day for seven days (Group 7) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACH15 50 mgACH15 50mg capsule | Drug | ACH15 - 50mg capsule |
| ACH15 250 mgACH15 250mg capsule | Drug | ACH15 - 250 mg capsule |
| ACH15 500mgACH15 500 mg capsule | Drug | ACH15 - 500mg capsule |
| ACH15 - 1000mgACH15 500mg capsule - two 500mg capsules in single dose | Drug | ACH15 - 1000 mg (two 500mg capsule) |
| ACH15 - 2000mgACH15 500mg capsule (four 500mg capsules in one dose) | Drug | ACH15 - 2000 mg (four 500 mg capsule) |
| ACH15 - 500mgACH15 - 500mg twice a day for 7 days | Drug | ACH15 - 500 mg (twice a day for 7 days) |
| Placebo 250 mgCapsule manufactured to mimic ACH15 250 mg capsule | Drug | Placebo - 250 mg capsule |
| Placebo 500mgCapsule manufactured to mimic ACH15 500 mg capsule | Drug | Placebo - 500 mg (twice a day for 7 days), Placebo - 500 mg capsule |
| Placebo 1000mgCapsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose) | Drug | Placebo - 1000 mg (two 500mg capsule) |
| Placebo 2000mgCapsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose) | Drug | Placebo 2000 mg (four 500mg capsule) |
| Placebo 500mgCapsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days) | Drug | Placebo - 500 mg (twice a day for 7 days), Placebo - 500 mg capsule |
Primary outcome
Blood pressure
Time frame: 30 days
Electrocardiogram
Time frame: 30 days
Echocardiography (participants included in Group 6)
Time frame: 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
High digestive endoscopy (participants included at Group 6)
Time frame: 8 days
Image exam to evaluate the drug safety
Blood analysis
Time frame: 30 days
Blood will be collected to evaluate the drug safety by analysis of biochemical profile
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sérgio Vencio, MD principal investigator
ICF - Instituto de Ciências Farmacêuticas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACH15 50 mg, ACH15 250 mg and ACH15 500mg in people with Healthy, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.