NCT02858271

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

July 20, 2016

Last Update Submit

August 3, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

  • Percent of radioactive dose recovered in urine and feces

    7 days

  • Concentration of total radioactivity in blood and plasma

    7 days

  • Cmax of AKB-9778 and any major metabolites identified

    7 days

  • Tmax of AKB-9778 and any major metabolites identified

    7 days

  • AUC of AKB-9778 and any major metabolites identified

    7 days

  • t1/2 of AKB-9778 and any major metabolites identified

    7 days

  • Elimination rate of AKB-9778 and any major metabolites identified

    7 days

Secondary Outcomes (1)

  • Incidence of adverse events and change in vital signs and laboratory values

    7 days

Study Arms (1)

AKB-9778

EXPERIMENTAL

Single dose of \[14C\]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1

Drug: AKB-9778 subcutaneous injection

Interventions

AKB-9778 subcutaneous injectionDRUG
AKB-9778

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18 - 33 kg/m2

You may not qualify if:

  • Significant cardiovascular, pulmonary, or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Akshay Buch, PhD

    Aerpio Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

August 8, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08