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

NCT02914262 | Completed Phase 1

• 1 other identifier: AKB-4924-CI-1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a double-blind, randomized, placebo-controlled, single ascending dose, Phase I study in healthy male subjects.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• 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

  8 days after a single oral dose

Study Arms (2)

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

Drug: AKB-4924

Placebo:Cohort 1-6

PLACEBO COMPARATOR

Intervention Placebo: Two subjects per cohort will receive single oral doses of placebo

Other: Placebo

Interventions

AKB-4924 DRUG

Comparison of different dosages of AKB-4924

Also known as: AKB-4924 Cohort 1-6

Experimental:Cohort 1-6 Experimental

Placebo OTHER

Placebo comparator

Also known as: Placebo Cohort 1-5

Placebo:Cohort 1-6

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aerpio Therapeutics: lead

Study Sites (1)

INC Research

Toronto, Canada

Location

MeSH Terms

Interventions

AKB-4924

Study Officials

• Michael McDonnell, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 26, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)