NCT05361668

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.

Detailed description

This is a Phase 2, randomized, open-label, parallel-group, multicenter study designed to evaluate the safety, pharmacokinetics, and efficacy of paltusotine treatment in subjects with carcinoid syndrome. The study was conducted in 2 parts: a Randomized Treatment Phase (RTP) which is completed, and an Open-label Extension (OLE) Phase which is still ongoing. The RTP consisted of paltusotine treatment for 8 weeks. Subjects who completed the RTP were eligible to enter the OLE Phase at the recommendation of the Investigator. In the ongoing OLE Phase, paltusotine is being administered for a further 102 weeks. The total duration of paltusotine treatment for the combined RTP and OLE Phase is up to 110 weeks (28 months).

Conditions

• Carcinoid Syndrome
• Carcinoid
• Carcinoid Tumor
• Carcinoid Tumor of Ileum
• Carcinoid Tumor of Cecum
• Carcinoid Syndrome Diarrhea
• Carcinoid Intestine Tumor
• Carcinoid Tumor of Liver
• Carcinoid Tumor of Pancreas

Interventions

Type	Name	Description
DRUG	Randomized: 40 mg Paltusotine	Two 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 80 mg)
DRUG	Randomized: 80 mg Paltusotine	Four 20 mg tablets QD (Potential post-randomization dose escalation based on efficacy and acceptable tolerability: up to 120 mg)

Timeline

• Start date: 2022-04-22
• Primary completion: 2024-03-07
• Completion: 2026-02-24
• First posted: 2022-05-05
• Last updated: 2026-03-19
• Results posted: 2025-10-31

Locations

35 sites across 7 countries: United States, Argentina, Brazil, Canada, Mexico, Peru, Poland

Regulatory

• FDA-regulated drug study