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NCT01392807
An Open-label, Single-center Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function Following Administration of a Single Dose of 25mg NKTR-118
Phase 1 trial testing NKTR-118 in Hepatic; Functional Disturbance in 24 participants. Completed in 1 November 2011.
1 November 2011
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 24 |
| Start date | 1 July 2011 |
| Primary completion | 1 November 2011 |
| Estimated completion | 1 November 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NKTR-118 — full drug profile →
Conditions studied
- Hepatic; Functional Disturbance — all drugs for Hepatic; Functional Disturbance →
Sponsor
AstraZeneca — full company profile →
Who can join
18 and older, any sex, with Hepatic; Functional Disturbance. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax)
Time frame: Duration from predose day 1 to day 6.
Sponsor's own description
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Population pharmacokinetics of naloxegol in a population of 1247 healthy subjects and patients.
Al-Huniti N, Chapel S, Xu H, Bui KH, et al · · 2016 · cited 20× · PMID 26317320 · DOI 10.1111/bcp.12756
Verify or expand the search:
- PubMed search for NCT01392807
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
- Trial protocol + status: ClinicalTrials.gov NCT01392807 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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/NCT01392807.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing