TerminatedPhase 1

A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Stopped: The recruitment was halted for strategic reasons

Denmark, France, Germany19 participantsStarted 2022-05-18

Plain-language summary

This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Known left ventricular ejection fraction \<50%, left ventricular hypertrophy, ventricular arrhythmias, bradycardia (heart rate \<50 beats per minute \[bpm\]), cardiomyopathy
✕. New York Heart Association Class ≥3 heart failure
✕. Congenital long QT syndrome or
✕. Known family history of long QT syndrome or sudden cardiac death before the age of 50
✕. Symptomatic Pulmonary embolism
✕. QT interval corrected for heart rate according to Fridericia's formula (QTcF) at screening \>450 milliseconds (msec) for males and \>470 msec for females, based on the average of a triplicate ECG

What they're measuring

Plasma Concentration of Debio 4126 in Acromegaly and GEP-NET Participants

Timeframe: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337

Trial details

NCT IDNCT05364944

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-29

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