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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949530
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Indalo Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Idiopathic Pulmonary Fibrosis Drug: IDL-2965 Oral Capsule Drug: Placebos Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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)
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IDL-2965 Oral Capsule
IDL-2965 oral capsule, single and multiple doses
 Drug: IDL-2965 Oral Capsule
Investigational drug
Placebo Comparator: Placebo Oral Capsule
Placebo oral capsule, single and multiple doses
 Drug: Placebos
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: Single Ascending Dose (SAD): up to 7 Days/ Multiple Ascending Dose (MAD): up to 21 Days/ IPF MAD: up to 40 Days ]
    Safety


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) [ Time Frame: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 40 Days ]
    Area under the plasma concentration-time curve from time zero to 24 hours


Other Outcome Measures:
  1. Exploratory Pharmacodynamic (PD) [ Time Frame: SAD: up to 7 Days / MAD: up to 21 Days / IPF MAD: up to 28 Days ]
    Change from baseline in phosphorylated small mothers against decapentaplegic (pSMAD) from bronchoalveolar lavage fluid cells


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949530


Contacts
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Contact: Business Operations 314-932-4032 ext 309 regulatory@indalotherapeutics.com

Locations
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United Kingdom
Covance CRU Recruiting
Leeds, United Kingdom
Contact: Business Operations    314-932-4032 ext 309    IT@indalotherapeutics.com   
Sponsors and Collaborators
Indalo Therapeutics, Inc.
Investigators
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Study Director: Jim Bush, MRCS FFPM Indalo Therapeutics, Inc.
More Information
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Responsible Party: Indalo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03949530    
Other Study ID Numbers: Indalo (IDL)-2965-IPF-001
2019-000173-23 ( EudraCT Number )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial