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Trial record 1 of 6 for:    aerpio
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Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02858271
First Posted: August 8, 2016
Last Update Posted: August 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aerpio Therapeutics
  Purpose
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers

Condition Intervention Phase
Healthy Drug: AKB-9778 subcutaneous injection Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose, Phase 1 Study to Assess the Absorption, Metabolism, Excretion, and Pharmacokinetics of [14C]-AKB-9778 in Healthy Male Volunteers

Further study details as provided by Aerpio Therapeutics:

Primary Outcome Measures:
  • Percent of radioactive dose recovered in urine and feces [ Time Frame: 7 days ]
  • Concentration of total radioactivity in blood and plasma [ Time Frame: 7 days ]
  • Cmax of AKB-9778 and any major metabolites identified [ Time Frame: 7 days ]
  • Tmax of AKB-9778 and any major metabolites identified [ Time Frame: 7 days ]
  • AUC of AKB-9778 and any major metabolites identified [ Time Frame: 7 days ]
  • t1/2 of AKB-9778 and any major metabolites identified [ Time Frame: 7 days ]
  • Elimination rate of AKB-9778 and any major metabolites identified [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Incidence of adverse events and change in vital signs and laboratory values [ Time Frame: 7 days ]

Enrollment: 6
Study Start Date: July 2016
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AKB-9778
Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1
Drug: AKB-9778 subcutaneous injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18 - 33 kg/m2

Exclusion Criteria:

  • Significant cardiovascular, pulmonary, or renal disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858271


Sponsors and Collaborators
Aerpio Therapeutics
Investigators
Study Chair: Akshay Buch, PhD Aerpio Therapeutics
  More Information

Responsible Party: Aerpio Therapeutics
ClinicalTrials.gov Identifier: NCT02858271     History of Changes
Other Study ID Numbers: AKB-9778-CI-3004
First Submitted: July 20, 2016
First Posted: August 8, 2016
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided