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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: NKTR118; Drug: NKTR118 Group1; Drug: NKTR118 Group 2; Drug: NKTR118 Group3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01372826

D3820C00009

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

NKTR118 Group1

Experimental group

Description:

Normal Renal Function

Treatment:

Drug: NKTR118 Group1

NKTR118 Group 2

Experimental group

Description:

Moderate Renal Function

Treatment:

Drug: NKTR118 Group 2

NKTR118 Group 3

Experimental group

Description:

Severe Renal Impairment

Treatment:

Drug: NKTR118 Group3

NKTR118 Group 4

Experimental group

Description:

End-Stage Renal Disease

Treatment:

Drug: NKTR118