Back to resultsA Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
Primary Purpose
Healthy Volunteers, Idiopathic Pulmonary Fibrosis
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
IDL-2965 Oral Capsule
Placebos
Sponsored by
About this trial
This is an interventional other trial for Healthy Volunteers
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.
Sites / Locations
- Covance CRU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IDL-2965 Oral Capsule
Placebo Oral Capsule
Arm Description
IDL-2965 oral capsule, single and multiple doses
Placebo oral capsule, single and multiple doses
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetic (PK)
Area under the plasma concentration-time curve from time zero to 24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949530
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
March 29, 2020 (Actual)
Study Completion Date
March 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indalo Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDL-2965 Oral Capsule
Arm Type
Experimental
Arm Description
IDL-2965 oral capsule, single and multiple doses
Arm Title
Placebo Oral Capsule
Arm Type
Placebo Comparator
Arm Description
Placebo oral capsule, single and multiple doses
Intervention Type
Drug
Intervention Name(s)
IDL-2965 Oral Capsule
Intervention Description
Investigational drug
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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.
Description
Safety
Time Frame
Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK)
Description
Area under the plasma concentration-time curve from time zero to 24 hours
Time Frame
SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days
Other Pre-specified Outcome Measures:
Title
Exploratory Pharmacodynamic (PD)
Description
Change from baseline in phosphorylated small mothers against decapentaplegic (pSMAD) from bronchoalveolar lavage fluid cells
Time Frame
SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Bush, MRCS FFPM
Organizational Affiliation
Indalo Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Covance CRU
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
We'll reach out to this number within 24 hrs