A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-16

Study Completion Date

2020-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the safety and tolerability of the drug candidate IDL-2965 and to see how it is absorbed, processed, and removed by the body.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Pharmacodynamics, and Pharmacokinetics of Orally Administered BLD-2660 in Subjects With IPF

NCT04244825

Idiopathic Pulmonary Fibrosis

WITHDRAWN PHASE2

Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis

NCT02503657

Idiopathic Pulmonary Fibrosis IPF

COMPLETED PHASE2

A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT02538536

Idiopathic Pulmonary Fibrosis (IPF)

COMPLETED PHASE2

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

NCT05975983

Idiopathic Pulmonary Fibrosis (IPF)

RECRUITING PHASE2

To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT01529853

Idiopathic Pulmonary Fibrosis

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

IDL-2965 is an oral integrin antagonist antifibrotic being studied as a potential treatment for IPF and Nonalcoholic Steatohepatitis (NASH). This double-blind, randomized, placebo-controlled, single and multiple oral dose study will be conducted in 3 parts. Part A will comprise a single-dose, sequential-group design in healthy subjects, incorporating a food-effect evaluation. Part B will consist of a multiple-dose, sequential-group design in healthy subjects. Part C will be a multiple-dose, sequential-group design in subjects with IPF.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers Idiopathic Pulmonary Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IDL-2965 Oral Capsule

IDL-2965 oral capsule, single and multiple doses

Group Type EXPERIMENTAL

IDL-2965 Oral Capsule

Intervention Type DRUG

Investigational drug

Placebo Oral Capsule

Placebo oral capsule, single and multiple doses

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IDL-2965 Oral Capsule

Investigational drug

Intervention Type DRUG

Placebos

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Healthy subjects:

• Male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg/m2.

IPF subjects:

* Male and female subjects over 40 years of age.
* Diagnosis of idiopathic pulmonary fibrosis
* Idiopathic pulmonary fibrosis has been stable for at least 3 months.

Exclusion Criteria

Healthy subjects and IPF subjects:

* Significant history or clinical manifestation of any disease/disorder, other than IPF.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound
* Poor peripheral venous access
* Use or intend to use any medications, tobacco or nicotine containing products or electronic cigarettes.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs

IPF subjects:

• Pulmonary function tests and other diagnostic procedures inconsistent with diagnosis of idiopathic pulmonary fibrosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes