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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Drug Induced Constipation

Treatments: Drug: Naloxegol; Drug: Diltiazem XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594619

D3820C00032

Details and patient eligibility

About

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

Full description

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 3 patient groups

A

Experimental group

Description:

Single dose naloxegol 25mg

Treatment:

Drug: Naloxegol

B

Active Comparator group

Description:

Diltiazem 240mg once daily day 4-6

Treatment:

Drug: Diltiazem XR

C

Active Comparator group

Description:

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

Treatment:

Drug: Naloxegol

Drug: Diltiazem XR