Clinical trial NCT03949530: A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Idiopathic Pulmonary Fibrosis
Lead sponsor: Indalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days
Secondary outcomes:
measure: Pharmacokinetic (PK)
timeFrame: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days
Other outcomes:
measure: Exploratory Pharmacodynamic (PD)
timeFrame: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 28 Days
Locations:
city: Leeds
country: United Kingdom
facility: Covance CRU
Study officials:
affiliation: Indalo Therapeutics, Inc.
name: Jim Bush, MRCS FFPM
role: STUDY_DIRECTOR
References: