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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

July 20, 2016
August 8, 2016
August 8, 2016
July 2016
July 2016   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Incidence of adverse events and change in vital signs and laboratory values [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778
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
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: AKB-9778 subcutaneous injection
Experimental: AKB-9778
Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1
Intervention: Drug: AKB-9778 subcutaneous injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
Same as current
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI 18 - 33 kg/m2

Exclusion Criteria:

  • Significant cardiovascular, pulmonary, or renal disease
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02858271
AKB-9778-CI-3004
No
Not Provided
Plan to Share IPD: Undecided
Aerpio Therapeutics
Aerpio Therapeutics
Not Provided
Study Chair: Akshay Buch, PhD Aerpio Therapeutics
Aerpio Therapeutics
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP