NCT03882762 is a Phase 1 clinical trial of Cebranopadol 200 μg tablet in Pharmacokinetic, sponsored by Tris Pharma, Inc..

Who is sponsoring NCT03882762?

NCT03882762 is sponsored by Tris Pharma, Inc..

What drugs are being tested in NCT03882762?

Interventions in NCT03882762: Cebranopadol 200 μg tablet.

What condition does NCT03882762 study?

NCT03882762 studies Pharmacokinetic.

Is NCT03882762 still recruiting?

NCT03882762 is currently completed. Last updated 15 July 2021.

Last reviewed 2021-07-15 · How we verify

NCT03882762

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

A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol

Completed Phase 1 Last updated 15 July 2021

What this trial tests

Phase 1 trial testing Cebranopadol 200 μg tablet in Pharmacokinetic in 34 participants. Completed in 17 September 2014.

Timeline

20 June 2013

Primary endpoint
17 September 2014

17 September 2014

Quick facts

Lead sponsor	Tris Pharma, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	20 June 2013
Primary completion	17 September 2014
Estimated completion	17 September 2014
Sites	2 locations across United States

Drugs / interventions tested

Cebranopadol 200 μg tablet — full drug profile →

Conditions studied

Pharmacokinetic — all drugs for Pharmacokinetic →

Sponsor

Tris Pharma, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Pharmacokinetic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study was to evaluate the pharmacokinetics (PK), safety and tolerability profile of cebranopadol (GRT6005) in patients with varying degree of renal impairment and participants with normal renal function after an oral single dose administration. This study was a Phase 1, multi-center, non-randomized, open-label, parallel group, single-dose study in up to 24 male and female patients with varying degree of renal impairment and participants with normal renal function. Within 14 days before the administration of cebranopadol the general eligibility of the participants for the study was assessed according to the inclusion/exclusion criteria. Estimated glomerular filtration rate (eGFR) was determined according to the Modification of Diet in Renal Disease (MDRD) equation. A treatment period from Day -1 to Day 8 was performed, with participant confinement to the study site from Day -1 to Day 6 and an outpatient visit on Day 8. A single dose of cebranopadol 200 μg was administered on Day 1. Multiple blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory monitoring. Additional blood samples were taken prior investigational medicinal product (IMP) administration to assess serum creatinine concentration and protein binding. An End-of-Trial Visit was performed at the time, or within 7 days, of the final blood sample on Day 8 or at early withdrawal.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Nociceptin Receptor-Related Agonists as Safe and Non-addictive Analgesics.
Ding H, Kiguchi N, Dobbins M, Romero-Sandoval EA, et al · · 2023 · cited 10× · PMID 37209211 · DOI 10.1007/s40265-023-01878-5

Verify or expand the search:

Other recruiting trials for Pharmacokinetic

Currently open trials in the same condition.

NCT07282093 — Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment · Phase 1 · recruiting

Other Tris Pharma, Inc. trials

Trials by the same sponsor.

NCT06545097 — A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty · Phase 3 · completed
NCT06423703 — A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy · Phase 3 · completed
NCT06453265 — A Study to Assess the Abuse Potential of Intranasal Cebranopadol · Phase 1 · completed
NCT05491785 — Cebranopadol Effects on Ventilatory Drive, Central Nervous System (CNS) and Pain. · Phase 1 · completed
NCT05256108 — Assessment of Abuse Potential of Cebranopadol in Humans · Phase 1 · completed

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 NCT03882762 (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 Tris Pharma, Inc.
Last refreshed: 15 July 2021

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/NCT03882762.

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