A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511922-30-00

Acronym

CRN00808-11

Enrollment

Registered

2024-08-06

Start date

2023-05-11

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoid Syndrome

Brief summary

Safety: Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from Baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose), Pharmacokinetics: Steady state trough levels at each dose at EOR

Interventions

DRUGPaltusotine tablets

DRUGOCTREOTIDE ACETATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of TEAEs, including serious TEAEs and TEAEs leading to discontinuation; change from Baseline to the EOR in safety parameters: clinical laboratory tests, physical exam findings, vital signs, 12-lead ECG, and 24-hour continuous cardiac monitoring (only for subjects on 120 mg dose), Pharmacokinetics: Steady state trough levels at each dose at EOR	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026