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NKTR-118/ Quinidine for Constipation

Phase 1
Waitlist Available
Led By Phil Leese, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics of NKTR-118

Eligible Conditions
  • Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: NKTR-118/ QuinidineActive Control2 Interventions
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)
Group II: NKTR-118/ Quinidine/ MorphineActive Control4 Interventions
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)
Group III: NKTR-118/ PlaceboPlacebo Group2 Interventions
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)
Group IV: NKTR-118/ Placebo/ MorphinePlacebo Group2 Interventions
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)

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,379 Previous Clinical Trials
288,740,076 Total Patients Enrolled
19 Trials studying Constipation
5,868 Patients Enrolled for Constipation
Mark Sostek, MDStudy DirectorAstrazeneca, Wilmington US
14 Previous Clinical Trials
587 Total Patients Enrolled
4 Trials studying Constipation
187 Patients Enrolled for Constipation
Phil Leese, MDPrincipal InvestigatorQuintiles Kansas United states
5 Previous Clinical Trials
409 Total Patients Enrolled
~16 spots leftby Oct 2025
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