Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-11-30

Brief Summary

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This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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NKTR118 Group1

Normal Renal Function

Group Type EXPERIMENTAL

NKTR118 Group1

Intervention Type DRUG

Oral dose, 25 mg

NKTR118 Group 2

Moderate Renal Function

Group Type EXPERIMENTAL

NKTR118 Group 2

Intervention Type DRUG

Oral dose, 25 mg

NKTR118 Group 3

Severe Renal Impairment

Group Type EXPERIMENTAL

NKTR118 Group3

Intervention Type DRUG

Oral dose, 25 mg

NKTR118 Group 4

End-Stage Renal Disease

Group Type EXPERIMENTAL

NKTR118

Intervention Type DRUG

Oral dose, 25 mg

Interventions

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NKTR118 Group1

Oral dose, 25 mg

Intervention Type DRUG

NKTR118 Group 2

Oral dose, 25 mg

Intervention Type DRUG

NKTR118 Group3

Oral dose, 25 mg

Intervention Type DRUG

NKTR118

Oral dose, 25 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed written and dated informed consent prior to any study specific procedures.
* Male or female volunteers aged 18 to 80 years (inclusive) having normal renal function, or suffering from moderate or severe renal impairment or ESRD.

Male subjects who are sexually active must be willing to use a barrier method of contraception (condom). Women must be of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test (at screening and at each admission) and be using a highly effective form of birth control for 3 months before enrollment and be willing to use a highly effective form of birth control during the study and until 3 months after their last dose of IP.

* Have a BMI between 18 and 40 kg/m2 (inclusive) and weigh at least 50 kg.
* Subjects must be able to understand and to comply with study procedures, restrictions and requirements.

Exclusion Criteria

* History of any clinically significant medical history which, in the opinion of the Investigator and Sponsor, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
* History or presence of gastrointestinal hepatic or other condition known to interfere with disposition of the study drug (except for renal function impairment).
* Subjects who have a functioning kidney transplant.
* Acute illness, surgical procedures or trauma from within 2 weeks before enrollment until first administration of study drug
* Known or suspected history of drug abuse as judged by the Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes