Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of Naloxegol
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Induced Constipation
Intervention: Naloxegol (Drug); Diltiazem XR (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Bo Fransson, MD, Study Chair, Affiliation: AstraZeneca, Sodertalje Sweden Dave Matthews, MD, Principal Investigator, Affiliation: Quintiles, Inc Kansas Overland Park US Mark Sostek, MD, Study Director, Affiliation: AstraZeneca, Wilmington US
Summary
Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics
of naloxegol.
Clinical Details
Official title: An Open-label, Sequential, 3-period Study to Assess the Effects of Diltiazem on the Pharmacokinetics of Naloxegol in Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
Secondary outcome: Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations, electrocardiograms, and Columbia-Suicide Severity Rating scaleDescription of the pharmacokinetic (PK) profile for naloxegol in terms of time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz). Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)]. Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to 24hours postdose [AUC(0 24)]. Description of the pharmacokinetic (PK) profile for naloxegol in terms of apparent oral clearance from plasma (CL/F), and apparent volume of distribution during the terminal phase (Vz/F)
Detailed description:
An Open-label, sequential, 3-period study to Assess the Effects of Diltiazem on the
Pharmacokinetics of Naloxegol in Healthy Subjects
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study-specific
procedures.
- Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18
to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
- Female volunteers must have negative pregnancy test (screening and admission), must
not be lactating, and must be of nonchildbearing potential, confirmed at screening by
being postmenopausal, or documentation of irreversible surgical sterilization not in.
- Male volunteers should be willing to use barrier contraception ie, condoms, from the
first day of dosing until 3 months after dosing with the IP. The female partner
should use contraception during this period.
- Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50
kg.
Exclusion Criteria:
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary,
gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may
put the volunteer at risk of participation in the study, or influence of the ADME of
drugs.
- Any clinically significant illness, medical/surgical procedure or trauma within 4
weeks of the first administration of IP.
- Any clinically significant abnormalities in clinical chemistry, hematology, or
urinalysis results as judged by the Investigator.
- Significant orthostatic reaction at enrolment, as judged by the Investigator.
- Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
Locations and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
Clinical_Study_Report_Synopsis_D3820C00032
Starting date: May 2012
Last updated: October 13, 2014
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