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Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

Sponsor
Akebia Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02502500
Collaborator
(none)
12
Enrollment
2
Arms
2
Duration (Months)

Study Details

Study Description

Brief Summary

To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Celecoxib

Celecoxib

Drug: Celecoxib
Other Names:
  • CELEBREX®

    		•
    Experimental: AKB-6548 and Celecoxib

    AKB-6548; celecoxib

    Drug: Celecoxib
    Other Names:
  • CELEBREX®

    • Drug: AKB-6548

    Outcome Measures

    Primary Outcome Measures

    1. PK parameters (Cmax) [pre-dose to 48 hours post-dose]

      maximum observed plasma concentration (Cmax) for celecoxib

    2. PK parameters (time to reach Cmax ) [pre-dose to 48 hours post-dose]

      time to reach Cmax for celecoxib

    3. PK parameters (t½) [from pre-dose to 48 hours post-dose]

      terminal elimination half-life (t½) for celecoxib

    4. PK parameters (AUC0-t) [pre-dose to 48 hours post-dose]

      concentration (AUC0-t) for celecoxib

    5. PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable) [pre-dose to 48 hours post-dose]

      area under the plasma concentration-time curve from 0 to last quantifiable

    6. PK parameters (AUC0-inf) [from pre-dose to 48 hours post-dose]

      AUC from time 0 to infinity (AUC0-inf) for celecoxib

    7. PK parameters (CL/F) [pre-dose to 48 hours post-dose]

      apparent oral clearance (CL/F) for celecoxib

    8. PK parameters (Vz/F) [pre-dose to 48 hours post-dose]

      apparent volume of distribution during the terminal phase (Vz/F) for celecoxib

    Secondary Outcome Measures

    1. Safety and Tolerability will be measured by vital signs [up to ten days]

      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

    2. Safety and Tolerability will be monitoring of adverse events (AEs) [up to ten days]

      The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for adverse events (AEs)

    3. Safety and Tolerability will be measured by clinical assays [up to ten days]

      The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for clinical laboratory assays

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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: 11.

    Exclusion Criteria:

    • 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.

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Akebia Therapeutics

    Investigators

    • Study Director: Akebia Therapeutics, Sponsor GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Akebia Therapeutics
    ClinicalTrials.gov Identifier:
    NCT02502500
    Other Study ID Numbers:
    • AKB-6548-CI-0019
    First Posted:
    Jul 20, 2015
    Last Update Posted:
    Nov 14, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Celecoxib

    Study Results

    No Results Posted as of Nov 14, 2018