HealthyPhase 1NCT02858271
Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778
A Phase 1 study testing AKB-9778 subcutaneous injection in people with Healthy, run by Aerpio Therapeutics.
Trial summary
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AKB-9778 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18 - 33 kg/m2
Who cannot join
- Significant cardiovascular, pulmonary, or renal disease
About this study
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
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers
- Conditions
- Healthy
- Being tested
- AKB-9778 subcutaneous injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-9778 subcutaneous injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| AKB-9778 | Experimental | Single dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1 Receives: Drug: AKB-9778 subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of radioactive dose recovered in urine and feces
Measured: 7 days
Concentration of total radioactivity in blood and plasma
Measured: 7 days
Cmax of AKB-9778 and any major metabolites identified
Measured: 7 days
Tmax of AKB-9778 and any major metabolites identified
Measured: 7 days
AUC of AKB-9778 and any major metabolites identified
Measured: 7 days
t1/2 of AKB-9778 and any major metabolites identified
Measured: 7 days
Elimination rate of AKB-9778 and any major metabolites identified
Measured: 7 days
Secondary outcomes (1)
Incidence of adverse events and change in vital signs and laboratory values
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerpio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akshay Buch, PhD, Study chair, Aerpio Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858271
- Sponsor's protocol ID
- AKB-9778-CI-3004
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858271
- Acronym / sponsor ID
- AKB-9778-CI-3004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aerpio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of [14C]-AKB-9778 in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKB-9778 | Experimental | Drug: AKB-9778 subcutaneous injectionSingle dose of [14C]-radiolabeled subcutaneous (SC) injection of AKB-9778 in the morning of Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18 - 33 kg/m2
Key exclusion criteria (1 listed)
- Significant cardiovascular, pulmonary, or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKB-9778 subcutaneous injection | Drug | AKB-9778 |
Primary outcome
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
1 secondary outcome
Incidence of adverse events and change in vital signs and laboratory values
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akshay Buch, PhD study chair
Aerpio Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AKB-9778 subcutaneous injection in people with Healthy, run by Aerpio Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of radioactive dose recovered in urine and feces (time frame: 7 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.