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Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

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ClinicalTrials.gov Identifier: NCT02502500
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Akebia Therapeutics

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
Healthy Volunteers Drug: Celecoxib Drug: AKB-6548 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 Type : Interventional  (Clinical Trial)
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 : July 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: Celecoxib
Celecoxib
Drug: Celecoxib
Other Name: CELEBREX®

Experimental: AKB-6548 and Celecoxib
AKB-6548; celecoxib
Drug: Celecoxib
Other Name: CELEBREX®

Drug: AKB-6548



Primary Outcome Measures :
  1. PK parameters (Cmax) [ Time Frame: pre-dose to 48 hours post-dose ]
    maximum observed plasma concentration (Cmax) for celecoxib

  2. PK parameters (time to reach Cmax ) [ Time Frame: pre-dose to 48 hours post-dose ]
    time to reach Cmax for celecoxib

  3. PK parameters (t½) [ Time Frame: from pre-dose to 48 hours post-dose ]
    terminal elimination half-life (t½) for celecoxib

  4. PK parameters (AUC0-t) [ Time Frame: 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) [ Time Frame: pre-dose to 48 hours post-dose ]
    area under the plasma concentration-time curve from 0 to last quantifiable

  6. PK parameters (AUC0-inf) [ Time Frame: from pre-dose to 48 hours post-dose ]
    AUC from time 0 to infinity (AUC0-inf) for celecoxib

  7. PK parameters (CL/F) [ Time Frame: pre-dose to 48 hours post-dose ]
    apparent oral clearance (CL/F) for celecoxib

  8. 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


Secondary Outcome Measures :
  1. Safety and Tolerability will be measured by vital signs [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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



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

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: *1*1.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502500


Sponsors and Collaborators
Akebia Therapeutics
Investigators
Study Chair: Akshay Buch Akebia Therapeutics Inc.

Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT02502500     History of Changes
Other Study ID Numbers: AKB-6548-CI-0019
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents