Renal Impairment
Conditions
Keywords
Phase 1, Pharmacokinetics, NKTR-118, renal impairment, parallel study, QTcF Interval, AUC(0-t), Cmax, tmax
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.
Interventions
DRUGNKTR118 Group1
Oral dose, 25 mg
DRUGNKTR118 Group 2
Oral dose, 25 mg
DRUGNKTR118 Group3
Oral dose, 25 mg
DRUGNKTR118
Oral dose, 25 mg
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) | 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) | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed