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

Healthy Volunteers Clinical Trial

Official title:

IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03949530
• Other study ID #: Indalo (IDL)-2965-IPF-001
• Secondary ID: 2019-000173-23
• Status: Terminated
• Phase: Phase 1
• Start date: April 16, 2019
• Est. completion date: March 29, 2020

Study information

• Verified date: July 2020
• Source: Indalo Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 29, 2020
• Est. primary completion date: March 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Healthy Volunteers
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• IDL-2965 Oral Capsule
Investigational drug
• Placebos
Placebo

Locations

Country	Name	City	State
United Kingdom	Covance CRU	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Indalo Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Pharmacodynamic (PD)	Change from baseline in phosphorylated small mothers against decapentaplegic (pSMAD) from bronchoalveolar lavage fluid cells	SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 28 Days
Primary	Incidence and severity of treatment emergent Adverse Events (AEs), AEs leading to discontinuation from Investigational Medicinal Product (IMP) or the study, serious adverse events (SAEs), and deaths.	Safety	Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days
Secondary	Pharmacokinetic (PK)	Area under the plasma concentration-time curve from time zero to 24 hours	SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days