Study To Evaluate The Safety, PK, And Dose Response Of Paltusotine In Subjects With Carcinoid Syndrome

Study Overview

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

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.

N/A

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

DRUG: Randomized: 40 mg Paltusotine
DRUG: Randomized: 80 mg Paltusotine

CRN00808-11

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-04-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-31
First Submitted that Met QC Criteria 2022-05-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-01
First Posted (ACTUAL) 2022-05-05	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 40 mg Paltusotine	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)
EXPERIMENTAL: 80 mg Paltusotine	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)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 40 mg Paltusotine

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)

EXPERIMENTAL: 80 mg Paltusotine

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)

Primary Outcome Measures	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)		Baseline to End of Randomized Treatment Phase (8 weeks)

Secondary Outcome Measures	Measure Description	Time Frame
Pharmacokinetics (PK) of paltusotine	Steady state trough levels at each dose at End of Randomized Treatment Phase (EOR)	Measured at Week 8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record