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OpenTrials
Completed

NCT Number: NCT02858271

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

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

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18 - 33 kg/m2

Exclusion criteria

  • Significant cardiovascular, pulmonary, or renal disease

Treatment and study plan

AKB-9778 subcutaneous injection

Drug

Primary outcomes

  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 outcomes

  1. Incidence of adverse events and change in vital signs and laboratory values

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Aerpio Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2016
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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