NCT01372826

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

Completed Phase 1 Last updated 13 October 2014

What this trial tests

Phase 1 trial testing NKTR118 Group1 in Renal Impairment in 32 participants. Completed in 1 November 2011.

Timeline

1 June 2011

Primary endpoint
1 October 2011

1 November 2011

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	32
Start date	1 June 2011
Primary completion	1 October 2011
Estimated completion	1 November 2011
Sites	3 locations across United States

Drugs / interventions tested

• NKTR118 Group1 — full drug profile →
• NKTR118 Group 2
• NKTR118 Group3
• NKTR118

Conditions studied

• Renal Impairment — all drugs for Renal Impairment →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 80, any sex, with Renal Impairment. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
  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.
  Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Population pharmacokinetics of naloxegol in a population of 1247 healthy subjects and patients.
   Al-Huniti N, Chapel S, Xu H, Bui KH, et al · · 2016 · cited 20× · PMID 26317320 · DOI 10.1111/bcp.12756