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

Purpose

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

Condition	Intervention	Phase
Renal Impairment	Drug: NKTR118 Group1 Drug: NKTR118 Group 2 Drug: NKTR118 Group3 Drug: NKTR118	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	An Open-Label, Parallel-Group, Phase I Study to Compare the Pharmacokinetics of NKTR-118 Following a Single Oral Dose in Subjects With Renal Impairment and Subjects With Normal Renal Function

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) [ Time Frame: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose. ] [ Designated as safety issue: No ]
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax) [ Time Frame: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose. ] [ Designated as safety issue: No ]
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)

Secondary Outcome Measures:

To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events. [ Time Frame: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs [ Time Frame: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples [ Time Frame: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment ] [ Designated as safety issue: Yes ]

Enrollment:	32
Study Start Date:	June 2011
Study Completion Date:	November 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NKTR118 Group1 Normal Renal Function	Drug: NKTR118 Group1 Oral dose, 25 mg
Experimental: NKTR118 Group 2 Moderate Renal Function	Drug: NKTR118 Group 2 Oral dose, 25 mg
Experimental: NKTR118 Group 3 Severe Renal Impairment	Drug: NKTR118 Group3 Oral dose, 25 mg
Experimental: NKTR118 Group 4 End-Stage Renal Disease	Drug: NKTR118 Oral dose, 25 mg

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372826

Locations

United States, California
Research Site
Anaheim, California, United States
United States, Florida
Research Site
Orlando, Florida, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Sostek, MD	AstraZeneca
Principal Investigator:	Thomas Marbury, MD	Orlando Clinical Research Center US

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01372826 History of Changes
Other Study ID Numbers:	D3820C00009
Study First Received:	May 25, 2011
Last Updated:	December 22, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by AstraZeneca:

Phase 1
Pharmacokinetics
NKTR-118
renal impairment
parallel study

QTcF Interval
AUC(0-t)
Cmax
tmax

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013