IBDPhase 1NCT02914262
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD Effects in Male Volunteers
A Phase 1 study testing AKB-4924 in people with IBD, run by Aerpio Therapeutics at 1 site in Canada.
Trial summary
This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- IBD
- What is being tested?
- AKB-4924
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Jan 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 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male subjects between 18 to 49 years of age, inclusive.
- Body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Who cannot join
- Non-vasectomized male subjects and their female partners who are unable or unwilling to use an acceptable method of contraception (as described in Section 8.1.3, Contraception and Pregnancy Avoidance Measures) during the study and for 30 days following the last dose of study medication.
- Evidence of active infection, unless the medical monitor and Investigator agree that the subject is appropriate for this study.
- Current or past history of chronic disease including, but not limited to, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, neurologic, renal, or liver disease.
- Diastolic blood pressure ≤55 mmHg or systolic blood pressure ≤100 mmHg at Screening.
- Clinically important or significant conduction abnormalities on ECG at Screening (including QTcF intervals >450 msec) and/or history of long QT syndrome. It is acceptable to repeat the ECG to confirm findings.
- Any history of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin or squamous cell carcinoma of skin, or resected benign colonic polyps.
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- Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibodies.
- Serum transaminase (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) levels >1.5X the upper limit of normal (ULN). If a subject presents with an abnormal AST and/or ALT results, the subject may be re-scheduled or the test may be repeated once at the discretion of the Investigator.
- Serum creatinine level ≥1.50 mg/dL. It is acceptable to repeat the test to confirm findings.
- Chronic daily medication use, except once daily over the counter multi-vitamin supplement.
- Subject has taken any prescription medication within 7 days (or 5 half-lives, whichever is longer) prior to admission to the CRU.
- Herbal supplements within 48 hours prior to dosing of study drug.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of Screening.
- Any history of alcohol or drug dependence within the previous year prior to Screening. Self-reported substance or alcohol dependence (excluding nicotine or caffeine) within the past 2 years, and/or have ever been in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence
- Any use of alcohol within 48 hours of admission to the CRU.
- Consumption of foods or beverages containing caffeine from 24 hours prior to dosing until the last sample collected during the Treatment period.
- Subjects with a known history of smoking and/or has used nicotine or nicotine-containing products within the past 6 months.
- Positive screen for drugs of abuse or a positive alcohol or cotinine result at screening or Day 1.
- Donation of blood or blood products during the 4 weeks prior to dosing of study drug.
- Physical activity greater than the normal level of activity from 48 hours prior to admission to the CRU.
- Use of an investigational medication or device or participation in an investigational study within 30 days or 5 half-lives of the investigational medication, whichever is longer, preceding Day 1, or ongoing or scheduled participation in another investigational study during the present study through the Day 8 Follow-Up.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the Investigator's judgment, would make the subject inappropriate for study entry.
- Known allergy to HPβCD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of AKB 4924 in Healthy Male Volunteers
This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.
Read the detailed description
Single oral doses of AKB-4924 will be investigated in up to 6 sequential cohorts of 8 healthy male subjects. Primarily 6 dose levels are planned; the proposed doses are 20 mg, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg. Actual doses may be decreased or increased based on the safety and tolerability of the drug, as determined by the Investigator and Sponsor. Additional cohorts may be added as needed to test lower, higher, or repeat doses.
- Conditions
- IBD
- Being tested
- AKB-4924, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-4924Drug
Also called AKB-4924 Cohort 1-6
Comparison of different dosages of AKB-4924
PlaceboOther
Also called Placebo Cohort 1-5
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Cohort 1-6 Experimental | Experimental | Intervention AKB 4924 Six subjects per cohort will receive single doses of 20 to up to 480 mg of AKB 4924 orally in a dose escalation format Receives: Drug: AKB-4924 |
| Placebo:Cohort 1-6 | Placebo comparator | Intervention Placebo:
Two subjects per cohort will receive single oral doses of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single ascending dose (SAD): Safety and tolerability of AKB-4924
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring
Measured: 8 days after a single oral dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerpio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McDonnell, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914262
- Sponsor's protocol ID
- AKB-4924-CI-1001
- Status last verified
- Mar 2017
- First submitted
- 16 Aug 2016
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of AKB 4924 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02914262
- Acronym / sponsor ID
- AKB-4924-CI-1001
- Conditions
- IBD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aerpio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Sep 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 will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.
Detailed description
Single oral doses of AKB-4924 will be investigated in up to 6 sequential cohorts of 8 healthy male subjects. Primarily 6 dose levels are planned; the proposed doses are 20 mg, 60 mg, 120 mg, 240 mg, 360 mg, and 480 mg. Actual doses may be decreased or increased based on the safety and tolerability of the drug, as determined by the Investigator and Sponsor. Additional cohorts may be added as needed to test lower, higher, or repeat doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Cohort 1-6 Experimental | Experimental | Drug: AKB-4924Intervention AKB 4924 Six subjects per cohort will receive single doses of 20 to up to 480 mg of AKB 4924 orally in a dose escalation format |
| Placebo:Cohort 1-6 | Placebo comparator | Other: PlaceboIntervention Placebo: Two subjects per cohort will receive single oral doses of placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between 18 to 49 years of age, inclusive.
- Body mass index (BMI) between 18 to 30 kg/m2, inclusive.
- Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
Key exclusion criteria (23 listed)
- Non-vasectomized male subjects and their female partners who are unable or unwilling to use an acceptable method of contraception (as described in Section 8.1.3, Contraception and Pregnancy Avoidance Measures) during the study and for 30 days following the last dose of study medication.
- Evidence of active infection, unless the medical monitor and Investigator agree that the subject is appropriate for this study.
- Current or past history of chronic disease including, but not limited to, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, neurologic, renal, or liver disease.
- Diastolic blood pressure ≤55 mmHg or systolic blood pressure ≤100 mmHg at Screening.
- Clinically important or significant conduction abnormalities on ECG at Screening (including QTcF intervals >450 msec) and/or history of long QT syndrome. It is acceptable to repeat the ECG to confirm findings.
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 |
|---|---|---|
| AKB-4924Also: AKB-4924 Cohort 1-6Comparison of different dosages of AKB-4924 | Drug | Experimental:Cohort 1-6 Experimental |
| PlaceboAlso: Placebo Cohort 1-5Placebo comparator | Other | Placebo:Cohort 1-6 |
Primary outcome
Single ascending dose (SAD): Safety and tolerability of AKB-4924
Time frame: 8 days after a single oral dose
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs and ECG monitoring
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 16 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Michael McDonnell, MD principal investigator
Syneos Health
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 AKB-4924 in people with IBD, run by Aerpio Therapeutics at 1 site in Canada.
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 23 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 16 Mar 2017. 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 Canada. 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 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?
Single ascending dose (SAD): Safety and tolerability of AKB-4924 (time frame: 8 days after a single oral dose). 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 16 Mar 2017.