Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD Effects in Male Volunteers

March 15, 2017 updated by: Aerpio Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • INC Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male subjects between 18 to 49 years of age, inclusive.
  2. Body mass index (BMI) between 18 to 30 kg/m2, inclusive.
  3. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

  1. 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.
  2. Evidence of active infection, unless the medical monitor and Investigator agree that the subject is appropriate for this study.
  3. Current or past history of chronic disease including, but not limited to, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, neurologic, renal, or liver disease.
  4. Diastolic blood pressure ≤55 mmHg or systolic blood pressure ≤100 mmHg at Screening.
  5. 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.
  6. 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.
  7. Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibodies.
  8. 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.
  9. Serum creatinine level ≥1.50 mg/dL. It is acceptable to repeat the test to confirm findings.
  10. Chronic daily medication use, except once daily over the counter multi-vitamin supplement.
  11. Subject has taken any prescription medication within 7 days (or 5 half-lives, whichever is longer) prior to admission to the CRU.
  12. Herbal supplements within 48 hours prior to dosing of study drug.
  13. 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.
  14. 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
  15. Any use of alcohol within 48 hours of admission to the CRU.
  16. Consumption of foods or beverages containing caffeine from 24 hours prior to dosing until the last sample collected during the Treatment period.
  17. Subjects with a known history of smoking and/or has used nicotine or nicotine-containing products within the past 6 months.
  18. Positive screen for drugs of abuse or a positive alcohol or cotinine result at screening or Day 1.
  19. Donation of blood or blood products during the 4 weeks prior to dosing of study drug.
  20. Physical activity greater than the normal level of activity from 48 hours prior to admission to the CRU.
  21. 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.
  22. 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.
  23. Known allergy to HPβCD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental:Cohort 1-6 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
Drug: AKB-4924
Comparison of different dosages of AKB-4924
Other Names:
  • AKB-4924 Cohort 1-6
PLACEBO_COMPARATOR: Placebo:Cohort 1-6

Intervention Placebo:

Two subjects per cohort will receive single oral doses of placebo
Other: Placebo
Placebo comparator
Other Names:
  • Placebo Cohort 1-5

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
8 days after a single oral dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aerpio Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AKB-4924-CI-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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