Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
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
1 other identifier
interventional
32
1 country
3
Brief Summary
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2011
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedOctober 15, 2014
October 1, 2014
4 months
May 25, 2011
October 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC)
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
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.
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax)
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
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.
Secondary Outcomes (3)
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events.
Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs
Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples
Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
Study Arms (4)
NKTR118 Group1
EXPERIMENTALNormal Renal Function
NKTR118 Group 2
EXPERIMENTALModerate Renal Function
NKTR118 Group 3
EXPERIMENTALSevere Renal Impairment
NKTR118 Group 4
EXPERIMENTALEnd-Stage Renal Disease
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Anaheim, California, United States
Research Site
Orlando, Florida, United States
Research Site
Overland Park, Kansas, United States
Related Publications (1)
Bui K, She F, Sostek M. The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1375-82. doi: 10.1002/jcph.349. Epub 2014 Jul 1.
PMID: 24946021DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Sostek, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Thomas Marbury, MD
Orlando Clinical Research Center US
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
June 14, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
October 15, 2014
Record last verified: 2014-10