Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of Naloxegol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-08-31

Brief Summary

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Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics of naloxegol.

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Detailed Description

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An Open-label, sequential, 3-period study to Assess the Effects of Diltiazem on the Pharmacokinetics of Naloxegol in Healthy Subjects

Conditions

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Drug Induced Constipation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

Single dose naloxegol 25mg

Group Type EXPERIMENTAL

Naloxegol

Intervention Type DRUG

Oral 25mg tablet

B

Diltiazem 240mg once daily day 4-6

Group Type ACTIVE_COMPARATOR

Diltiazem XR

Intervention Type DRUG

Oral 240mg tablet

C

Diltiazem 240mg once daily day 7 and 8. Single dose naloxegol 25mg day 7

Group Type ACTIVE_COMPARATOR

Naloxegol

Intervention Type DRUG

Oral 25mg tablet

Diltiazem XR

Intervention Type DRUG

Oral 240mg tablet

Interventions

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Naloxegol

Oral 25mg tablet

Intervention Type DRUG

Diltiazem XR

Oral 240mg tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes