NCT01533155 is a Phase 1 clinical trial of Nektar 118 in Drug Induced Constipation, sponsored by AstraZeneca.

Who is sponsoring NCT01533155?

NCT01533155 is sponsored by AstraZeneca.

What drugs are being tested in NCT01533155?

Interventions in NCT01533155: Nektar 118, Quinidine, Quinidine placebo, Morphine.

What condition does NCT01533155 study?

NCT01533155 studies Drug Induced Constipation.

Is NCT01533155 still recruiting?

NCT01533155 is currently completed. Last updated 13 October 2014.

Last reviewed 2014-10-13 · How we verify

NCT01533155

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 13 October 2014

What this trial tests

Phase 1 trial testing Nektar 118 in Drug Induced Constipation in 214 participants. Completed in 1 September 2012.

Timeline

1 March 2012

Primary endpoint
1 September 2012

1 September 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	214
Start date	1 March 2012
Primary completion	1 September 2012
Estimated completion	1 September 2012
Sites	1 location across United States

Drugs / interventions tested

Nektar 118 — full drug profile →
Quinidine — full drug profile →
Quinidine placebo — full drug profile →
Morphine

Conditions studied

Drug Induced Constipation — all drugs for Drug Induced Constipation →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 55, any sex, with Drug Induced Constipation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Description of the pharmacokinetic (PK) profile for NKTR- 118 in terms of maximum observed plasma concentration (Cmax), time to Cmax (tmax), apparent terminal half-life (t1/2λz).
Time frame: At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR- 118 in terms of apparent terminal rate constant (λz), area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC).
Time frame: At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)].
Time frame: At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR 118 in terms of area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)].
Time frame: At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.
Description of the PK profile for NKTR 118 in terms of apparent oral clearance from plasma (CL/F), and apparent volume of distribution during the terminal phase (Vz/F).
Time frame: At predose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours postdose.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other AstraZeneca trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01533155 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 13 October 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01533155.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing