DiarrheaPhase 1NCT02949089
ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
A Phase 1 study testing ACH04 in people with Diarrhea, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals. 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
- Diarrhea
- What is being tested?
- ACH04
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Sep 2014
- 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
- Subjects will be healthy males subjects between 18 and 50 years of age;
- Subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations;
- Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions.
Who cannot join
- Subjects with hypersensitivity known to Psidium guajava L. or history of serious adverse events;
- Subjects who have a significant history of alcoholism or drug/chemical abuse;
- Subjects who have body mass index < 18 or > 30;
- Subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start;
- Subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive;
- Subjects who were hospitalized for any reason in the six week prior the study start;
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- Subjects who, in the opinion of the investigator, should not participate in the study, including subjects suspected for whatever reason of not being able to comply with the requirements of the protocol;
- Subjects who are participating in a clinical trial or have participated in a clinical study involving administration of an investigational drug, within one year;
- Subjects who are relatives of employees from the sponsor and the site, respectively;
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, dermatological or other major disorders as determined by the Investigator;
- Any finding of clinical observation (anamnesis and physical evaluation), laboratory abnormality, who in the investigator opinion, may jeopardize the subjects or interfere with the study goals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Dose Escalation Study of ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.
- Conditions
- Diarrhea
- Being tested
- ACH04
- Keywords
- safety, tolerability, rising multiple doses, ACH04, adult, male
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH04Drug
The subjects will receive the study medication in each group
| Study group | Role | What they receive |
|---|---|---|
| ACH04 | Experimental | Dosage: 1 capsule, PO, 24/24h for 10 days. Receives: Drug: ACH04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of rising multiple doses of ACH04
Evaluate the occurrence of adverse events, Assess safety through laboratory tests and Assess safety through electrocardiogram
Measured: up to 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949089
- Sponsor's protocol ID
- ACH-PSD-01(04/11)
- Status last verified
- Oct 2016
- First submitted
- 3 May 2011
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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
- An Open Label, Dose Escalation Study of ACH04 to Assess the Safety and Tolerability in Healthy Adults Subjects
- ClinicalTrials.gov ID
- NCT02949089
- Acronym / sponsor ID
- ACH-PSD-01(04/11)
- Conditions
- Diarrhea
- Keywords
- safety, tolerability, rising multiple doses, ACH04, adult, male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Oct 2016 (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.
This study intends to provide information on the safety and tolerability of repeated oral doses of ACH04. A phase I, single-center, first in human, open-label, dose escalation study of ACH04 to assess the safety and tolerability in healthy adults subjects is selected to best address the study goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACH04 | Experimental | Drug: ACH04Dosage: 1 capsule, PO, 24/24h for 10 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects will be healthy males subjects between 18 and 50 years of age;
- Subjects must be in good healthy as determined by a medical history, physical examination and clinical laboratory evaluations;
- Subjects will, prior to any study related activities, have given their written informed consent to participate in the study and to abide by the stdy restrictions.
Key exclusion criteria (11 listed)
- Subjects with hypersensitivity known to Psidium guajava L. or history of serious adverse events;
- Subjects who have a significant history of alcoholism or drug/chemical abuse;
- Subjects who have body mass index < 18 or > 30;
- Subjects who have received any medications that is known to have a toxic potential well defined in large organs within the past 3 months prior the study start;
- Subjets who doesn´t agree to use, for the duration of the study, a barrier contraceptive;
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 |
|---|---|---|
| ACH04The subjects will receive the study medication in each group | Drug | ACH04 |
Primary outcome
Evaluate the safety of rising multiple doses of ACH04
Time frame: up to 39 days
Evaluate the occurrence of adverse events, Assess safety through laboratory tests and Assess safety through electrocardiogram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ACH04 in people with Diarrhea, 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 3 inclusion and 11 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: finished, 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the safety of rising multiple doses of ACH04 (time frame: up to 39 days). 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.