Healthy VolunteersPhase 1NCT02502500
Effect of AKB-6548 on the Pharmacokinetics of Celecoxib
A Phase 1 study testing Celecoxib and AKB-6548 in people with Healthy Volunteers, run by Akebia Therapeutics.
Trial summary
To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Celecoxib and AKB-6548
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Sep 2015
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/sq.meters, inclusive.
- Subjects with the following genotype based upon pharmacogenetic testing results: CYP2C9 EM: *1*1.
Who cannot join
- Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
- Positive serology results for HBsAg, HCV, and HIV at Screening.
- Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/minute/1.73 sq.meters.
- Known hypersensitivity to celecoxib or sulfonamides.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Known active cancer or history of chemotherapy use within the previous 24 months.
Show all 10Show fewer
- Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
- Current or past history of gastrointestinal bleeding.
- Any history of alcohol or drug abuse within the previous year prior to Screening.
- Subjects with a known history of smoking and/or have used nicotine or nicotine containing products within the past 6 months.
About this study
Official title: An Open-label Study in Healthy Subjects to Assess the Effect of Once-daily Multiple Dosing of AKB-6548 on the Pharmacokinetics of the CYP2C9 Substrate Celecoxib
To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.
Read the detailed description
To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.
- Conditions
- Healthy Volunteers
- Being tested
- Celecoxib, AKB-6548
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called CELEBREX®
AKB-6548Drug
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Active comparator | Celecoxib Receives: Drug: Celecoxib |
| AKB-6548 and Celecoxib | Experimental | AKB-6548; celecoxib Receives: Drug: Celecoxib; Drug: AKB-6548 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters (Cmax)
maximum observed plasma concentration (Cmax) for celecoxib
Measured: pre-dose to 48 hours post-dose
PK parameters (time to reach Cmax )
time to reach Cmax for celecoxib
Measured: pre-dose to 48 hours post-dose
PK parameters (t½)
terminal elimination half-life (t½) for celecoxib
Measured: from pre-dose to 48 hours post-dose
PK parameters (AUC0-t)
concentration (AUC0-t) for celecoxib
Measured: pre-dose to 48 hours post-dose
PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable)
area under the plasma concentration-time curve from 0 to last quantifiable
Measured: pre-dose to 48 hours post-dose
PK parameters (AUC0-inf)
AUC from time 0 to infinity (AUC0-inf) for celecoxib
Measured: from pre-dose to 48 hours post-dose
PK parameters (CL/F)
apparent oral clearance (CL/F) for celecoxib
Measured: pre-dose to 48 hours post-dose
PK parameters (Vz/F)
apparent volume of distribution during the terminal phase (Vz/F) for celecoxib
Measured: pre-dose to 48 hours post-dose
Secondary outcomes (3)
Safety and Tolerability will be measured by vital signs
The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for vital signs, clinical laboratory assays
Measured: up to ten days
Safety and Tolerability will be monitoring of adverse events (AEs)
The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for adverse events (AEs)
Measured: up to ten days
Safety and Tolerability will be measured by clinical assays
The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for clinical laboratory assays
Measured: up to ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akebia Therapeutics, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502500
- Sponsor's protocol ID
- AKB-6548-CI-0019
- Status last verified
- Nov 2018
- First submitted
- 13 Jul 2015
- Last updated
- 14 Nov 2018
- 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 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study in Healthy Subjects to Assess the Effect of Once-daily Multiple Dosing of AKB-6548 on the Pharmacokinetics of the CYP2C9 Substrate Celecoxib
- ClinicalTrials.gov ID
- NCT02502500
- Acronym / sponsor ID
- AKB-6548-CI-0019
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Jul 2015 (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.
To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.
Detailed description
To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Active comparator | Drug: CelecoxibCelecoxib |
| AKB-6548 and Celecoxib | Experimental | Drug: Celecoxib, Drug: AKB-6548AKB-6548; celecoxib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/sq.meters, inclusive.
- Subjects with the following genotype based upon pharmacogenetic testing results: CYP2C9 EM: *1*1.
Key exclusion criteria (10 listed)
- Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
- Positive serology results for HBsAg, HCV, and HIV at Screening.
- Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/minute/1.73 sq.meters.
- Known hypersensitivity to celecoxib or sulfonamides.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
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 |
|---|---|---|
| CelecoxibAlso: CELEBREX® | Drug | AKB-6548 and Celecoxib, Celecoxib |
| AKB-6548 | Drug | AKB-6548 and Celecoxib |
Primary outcome
PK parameters (Cmax)
Time frame: pre-dose to 48 hours post-dose
maximum observed plasma concentration (Cmax) for celecoxib
PK parameters (time to reach Cmax )
Time frame: pre-dose to 48 hours post-dose
time to reach Cmax for celecoxib
PK parameters (t½)
Time frame: from pre-dose to 48 hours post-dose
terminal elimination half-life (t½) for celecoxib
PK parameters (AUC0-t)
Time frame: pre-dose to 48 hours post-dose
concentration (AUC0-t) for celecoxib
PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable)
Time frame: pre-dose to 48 hours post-dose
area under the plasma concentration-time curve from 0 to last quantifiable
PK parameters (AUC0-inf)
Time frame: from pre-dose to 48 hours post-dose
AUC from time 0 to infinity (AUC0-inf) for celecoxib
PK parameters (CL/F)
Time frame: pre-dose to 48 hours post-dose
apparent oral clearance (CL/F) for celecoxib
PK parameters (Vz/F)
Time frame: pre-dose to 48 hours post-dose
apparent volume of distribution during the terminal phase (Vz/F) for celecoxib
3 secondary outcomes
Safety and Tolerability will be measured by vital signs
Time frame: up to ten days
Safety and Tolerability will be monitoring of adverse events (AEs)
Time frame: up to ten days
Safety and Tolerability will be measured by clinical assays
Time frame: up to ten 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 14 Nov 2018.
- 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.
Akebia Therapeutics study director
Sponsor GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib and AKB-6548 in people with Healthy Volunteers, run by Akebia 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 2 inclusion and 10 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 14 Nov 2018. 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?
PK parameters (Cmax) (time frame: pre-dose to 48 hours post-dose). The study lists 8 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 14 Nov 2018.