Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-04-30

Brief Summary

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Study in healthy volunteers to investigate the effects of Ketoconazole on the Pharmacokinetics of NKTR-118

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Detailed Description

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An Open-label, 1-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118 in Healthy Subjects

Conditions

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Bioavailability Healthy Volunteers Drug- Drug Interactions

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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Part 1 - A

Single dose NKTR-118 25 mg on Day 1 only

Group Type EXPERIMENTAL

NKTR-118

Intervention Type DRUG

Oral 25 mg

Part 1 - B

Ketoconazole 400 mg once daily on Days 4 to 8

Group Type ACTIVE_COMPARATOR

Ketoconazole

Intervention Type DRUG

Oral 400 mg

Part 1- C

Ketoconazole 400 mg plus NKTR-118 25 mg on Day 7

Group Type ACTIVE_COMPARATOR

NKTR-118

Intervention Type DRUG

Oral 25 mg

Ketoconazole

Intervention Type DRUG

Oral 400 mg

Interventions

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NKTR-118

Oral 25 mg

Intervention Type DRUG

Ketoconazole

Oral 400 mg

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 a negative pregnancy test at screening and at admission, must not be lactating, and must be of nonchildbearing potential.
* 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, metabolic, malignant, psychiatric, or major physical impairment), as judged by the Investigator.
* 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 enrollment 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