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

NCT05361668 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-19

Study results available
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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.

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

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)

Sponsors & Collaborators

  • Crinetics Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2024-03-07
Completion
2026-02-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Mexico
  • Peru
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361668 on ClinicalTrials.gov