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Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778

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ClinicalTrials.gov Identifier: NCT02858271
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Aerpio Therapeutics

Brief Summary:
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: AKB-9778 subcutaneous injection Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : July 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
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



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

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


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

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

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