NCT03882762

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

A Non-randomized, Single-dose, Open-Label, Pharmacokinetic Study of Cebranopadol in Patients With Impaired Renal Function and Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	Cebranopadol 200 μg tablet	200 μg cebranopadol film-coated tablet was taken with 240 mL of water under fed conditions.

Timeline

• Start date: 2013-06-20
• Primary completion: 2014-09-17
• Completion: 2014-09-17
• First posted: 2019-03-20
• Last updated: 2021-07-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study