Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118
Status and phase
Completed
Phase 1
Conditions
Drug Induced Constipation
Treatments
Drug: Morphine
Drug: Quinidine placebo
Drug: Nektar 118
Drug: Quinidine
Details and patient eligibility
About
Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics of NKTR-118
Full description
A Randomized, 2-Part, Crossover, Single Center Study to Evaluate Effect of Quinidine on the Pharmacokinetics of NKTR-118 and the Concomitant Effect of Quinidine and NKTR-118 on Morphine-induced Miosis
Enrollment
214 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
- Female volunteers must be nonpregnant and nonlactating. Women of childbearing potential must have negative pregnancy test (screening and admission) and be using a highly-effective form of birth control for 3 months before enrollment.
- Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
- Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.
Exclusion criteria
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may put the volunteer at risk of participation in the study, or influence of the ADME of drugs.
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
- History (personal or family) of torsades de pointes, any other polymorphic ventricular tachycardia, long QT syndrome, sudden death or Brugada syndrome, or personal history of sustained (greater than 30 s) monomorphic ventricular tachycardia.
- Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
214 participants in 4 patient groups, including a placebo group
NKTR-118/ Quinidine
Active Comparator group
Description:
One 25-mg NKTR-118 tablet will be administered once with 3 Quinidine 200mg tablets in the morning of period 1 or period 2 (part 1)
Treatment:
Drug: Quinidine
Drug: Nektar 118
NKTR-118/ Placebo
Placebo Comparator group
Description:
One 25-mg NKTR-118 tablet will be administered once with 3 Placebo tablets in the morning of period 1 or period 2 (part 1)
Treatment:
Drug: Quinidine placebo
Drug: Nektar 118
NKTR-118/ Quinidine/ Morphine
Active Comparator group
Description:
One 25-mg NKTR-118 tablet will be administered with 3 Quinidine 200mg tablets with Morphine inj 5mg/70kg once in the morning on period 3 or period 4 (Part 2)
Treatment:
Drug: Quinidine placebo
Drug: Quinidine
Drug: Morphine
Drug: Nektar 118
NKTR-118/ Placebo/ Morphine
Placebo Comparator group
Description:
One 25-mg NKTR-118 tablet will be administered with 3 placebo tables with Morphine inj 5mg/70kg once in the morning of period 3 or period 4 (part 2)
Treatment:
Drug: Morphine
Drug: Nektar 118
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems