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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372826
• Other study ID #: D3820C00009
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2011
• Last updated: October 13, 2014
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• NKTR118 Group1
Oral dose, 25 mg
• NKTR118 Group 2
Oral dose, 25 mg
• NKTR118 Group3
Oral dose, 25 mg
• NKTR118
Oral dose, 25 mg

Locations

Country	Name	City	State
United States	Research Site	Anaheim	California
United States	Research Site	Orlando	Florida
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

•   D3820C00009 Clinical Study Report Synopsis