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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NKTR118 Group1

NKTR118 Group 2

NKTR118 Group3

NKTR118

About this trial

This is an interventional basic science trial for Renal Impairment focused on measuring Phase 1, Pharmacokinetics, NKTR-118, renal impairment, parallel study, QTcF Interval, AUC(0-t), Cmax, tmax

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

NKTR118 Group1

NKTR118 Group 2

NKTR118 Group 3

NKTR118 Group 4

Arm Description

Normal Renal Function

Moderate Renal Function

Severe Renal Impairment

End-Stage Renal Disease

Outcomes

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)

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)

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.

To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs

To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples

Full Information

NCT ID

NCT01372826

First Posted

May 25, 2011

Last Updated

October 13, 2014

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01372826

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

Phase 1, Pharmacokinetics, NKTR-118, renal impairment, parallel study, QTcF Interval, AUC(0-t), Cmax, tmax

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NKTR118 Group1

Arm Type

Experimental

Arm Description

Normal Renal Function

Arm Title

NKTR118 Group 2

Arm Type

Experimental

Arm Description

Moderate Renal Function

Arm Title

NKTR118 Group 3

Arm Type

Experimental

Arm Description

Severe Renal Impairment

Arm Title

NKTR118 Group 4

Arm Type

Experimental

Arm Description

End-Stage Renal Disease

Intervention Type

Drug

Intervention Name(s)

NKTR118 Group1

Intervention Description

Oral dose, 25 mg

Intervention Type

Drug

Intervention Name(s)

NKTR118 Group 2

Intervention Description

Oral dose, 25 mg

Intervention Type

Drug

Intervention Name(s)

NKTR118 Group3

Intervention Description

Oral dose, 25 mg

Intervention Type

Drug

Intervention Name(s)

NKTR118

Intervention Description

Oral dose, 25 mg

Primary Outcome Measure Information:

Title

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

Description

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

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.

Title

To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax)

Description

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

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.

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Sostek, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Thomas Marbury, MD

Organizational Affiliation

Orlando Clinical Research Center US

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Anaheim

State/Province

California

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Overland Park

State/Province

Kansas

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24946021

Citation

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1391&filename=D3820C00009_Clinical_Study_Report_Synopsis.pdf

Description

D3820C00009 Clinical Study Report Synopsis

Learn more about this trial

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

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