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Completed

NCT Number: NCT01372826

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NKTR118 Group1

Drug

Oral dose, 25 mg

NKTR118 Group 2

Drug

Oral dose, 25 mg

NKTR118 Group3

Drug

Oral dose, 25 mg

NKTR118

Drug

Oral dose, 25 mg

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)

    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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2011
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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