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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 scale

Description 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

Page last updated: August 23, 2015

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