NCT01392807

Brief Summary

The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

July 8, 2011

Last Update Submit

October 13, 2014

Conditions

Hepatic; Functional Disturbance

Keywords

Phase 1volunteers with hepatic impairmentpharmacokineticsNKTR-118Child-Pugh scaleAUCCmaxtmaxt1/2

Outcome Measures

Primary Outcomes (1)

  • To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax)

    Duration from predose day 1 to day 6.

Secondary Outcomes (3)

  • To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events.

    Duration from day -1 to follow up. ( Approximately 15-18 days)

  • To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs

    Duration from day -1 to follow up. ( Approximately 15-18 days)

  • To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples

    Duration from day -1 to follow up. ( Approximately 15-18 days)

Study Arms (3)

Group 1

EXPERIMENTAL

Normal hepatic function, 25 mg NKTR-118 administered orally

Drug: NKTR-118

Group 2

EXPERIMENTAL

Mild hepatic impairment, 25 mg NKTR-118 administered orally

Drug: NKTR-118

Group 3

EXPERIMENTAL

Moderate hepatic impairment, 25 mg NKTR-118 administered orally

Drug: NKTR-118

Interventions

NKTR-118DRUG

25 mg Oral tablets, single dose

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive.
  • Negative screen for human immunodeficiency virus (HIV)
  • For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV

You may not qualify if:

  • Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
  • Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator.
  • Subjects with a history of surgery on the gastrointestinal tract.
  • For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • Bui K, She F, Sostek M. The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1368-74. doi: 10.1002/jcph.348. Epub 2014 Jun 27.

    PMID: 24945932DERIVED

Related Links

MeSH Terms

Interventions

naloxegol

Study Officials

  • Mark Sostek, MD

    AstraZeneca

    STUDY DIRECTOR

  • Thomas Marbury, MD

    Orlando Clinical Research Center

    PRINCIPAL INVESTIGATOR

  • Bo Fransson, MD

    AstraZeneca

    STUDY CHAIR

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

July 8, 2011

First Posted

July 13, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)