Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778
August 3, 2016 updated by: Aerpio Therapeutics
An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
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
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI 18 - 33 kg/m2
Exclusion Criteria:
- Significant cardiovascular, pulmonary, or renal disease
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AKB-9778
Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent of radioactive dose recovered in urine and feces
Time Frame: 7 days
|
7 days
|
|
Concentration of total radioactivity in blood and plasma
Time Frame: 7 days
|
7 days
|
|
Cmax of AKB-9778 and any major metabolites identified
Time Frame: 7 days
|
7 days
|
|
Tmax of AKB-9778 and any major metabolites identified
Time Frame: 7 days
|
7 days
|
|
AUC of AKB-9778 and any major metabolites identified
Time Frame: 7 days
|
7 days
|
|
t1/2 of AKB-9778 and any major metabolites identified
Time Frame: 7 days
|
7 days
|
|
Elimination rate of AKB-9778 and any major metabolites identified
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of adverse events and change in vital signs and laboratory values
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Akshay Buch, PhD, 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
July 1, 2016
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 20, 2016
First Submitted That Met QC Criteria
August 3, 2016
First Posted (Estimate)
August 8, 2016
Study Record Updates
Last Update Posted (Estimate)
August 8, 2016
Last Update Submitted That Met QC Criteria
August 3, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- AKB-9778-CI-3004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.