Safety and PK Study of CC-90001 in Subjects With Pulmonary Fibrosis

NCT02510937 | Completed Phase 1

• 1 other identifier: CC-90001-CP-003
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 6

Brief Summary

Participation in the study will last for 3months, with a 1 month screening phase.

Conditions

Pulmonary Fibrosis

Keywords

pulmonary fibrosis; pharmacokinetic; pharmacodynamics; CC-90001; Safety

Outcome Measures

Primary Outcomes (8)

• Adverse Events (AEs)

  Number of subjects with adverse events

  up to 16 weeks

• Dose interruptions, reductions, and discontinuation

  Number of subjects experiencing dose interruptions, reductions, and discontinuation of CC-90001 secondary to an AE

  up to 16 weeks

• Complete PEs

  Complete Physical Examinations

  up to 16 weeks

• Clinical laboratory assessments

  Clinical laboratory assessments

  up to 16 weeks

• Vital sign measurements

  Heart rate (HR), respiratory rate, blood pressure (BP), and body temperature

  up to 16 weeks

• 12-lead ECGs

  12-lead ECGs

  up to 16 weeks

• Urine pregnancy tests

  Urine pregnancy tests

  up to 16 weeks

• Concomitant medications and procedures

  Concomitant medications and procedures

  up to 16 weeks

Secondary Outcomes (2)

• CC-90001 plasma concentrations

  up to 16 weeks

• Population-based PK

  up to 16 weeks

Study Arms (2)

Low dose CC-90001

EXPERIMENTAL

Low dose (100 mg) CC-90001 administered orally once daily (QD) for 12 continuous weeks

Drug: CC-90001

High dose CC-90001

EXPERIMENTAL

High-dose (200 mg) CC-90001 administered orally Once Daily (QD) for 12 continuous weeks

Drug: CC-90001

Interventions

CC-90001 DRUG

High dose CC-90001; Low dose CC-90001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled into the study:
• Subject ≥ 18 years of age.
• Documented clinical diagnosis of a fibrotic lung disease supported by at least one of the following:
• Usual interstitial pneumonia (UIP) pattern based on high-resolution computed tomography (HRCT).
• Nonspecific interstitial pneumonia (NSIP) pattern based on HRCT. OR
• A documented fibrotic NSIP on surgical lung biopsy. OR
• A documented UIP pattern on surgical lung biopsy. The underlying etiology of the fibrotic lung disease may be of any cause, including, but NOT LIMITED TO any of the following: Connective tissue disease associated interstitial lung disease, idiopathic pulmonary fibrosis (IPF), environmental or chemical-related pulmonary fibrosis, other forms of interstitial pulmonary fibrosis, Hermansky-Pudlak syndrome.
• Must understand and voluntarily sign a written Informed Consent Form prior to any study-related procedures being performed.
• Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
• Asparate Aminotransferase (AST) or serum glutamic-oxaloacetic transaminase within limits of normal.
• Alanine Aminotransferase (ALT) or serum glutamic pyruvic transaminase within limits of normal.
• Total bilirubin and International Normalized Ratio (INR) within limits of normal.
• No clinically significant laboratory test results as determined by the Investigator.
• Male subjects agree to use barrier contraception NOT made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) while on CC 90001 and for at least 28 days after the last dose of study medication. A FCBP is defined as a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or who has not been naturally postmenopausal for at least 24 consecutive months (ie, who has had menses at any time in the preceding 24 consecutive months).
• All FCBPs must have a negative pregnancy test at Screening and Day 1. Any FCBP who engages in activity in which conception is possible must use two forms of contraception simultaneously while on CC-90001 and for at least 28 days after taking the last dose of CC-90001: one highly effective form (ie, hormonal, intrauterine device, tubal ligation, vasectomized partner) and one additional form (latex condom or any nonlatex condom NOT made of natural \[animal\] membrane \[eg, polyurethane\], diaphragm, sponge). If one highly effective form of contraception cannot be used, then two forms of barrier contraception must be used, ie, latex condom or any nonlatex condom NOT made out of natural (animal) membrane \[eg, polyurethane\] with either of the following: sponge with spermicide or diaphragm with spermicide.

You may not qualify if:

• Potential subjects will be excluded from enrollment if any of the following occur:
• Exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose of CC-90001 administration, or five half-lives of that investigational drug, if known (whichever is longer).
• Subjects who are part of the clinical staff personnel or family members of the study site staff.
• Screening forced vital capacity (FVC) \< 40% predicted.
• Screening lung diffusion capacity (DLco) \< 20% predicted.
• Any condition other than pulmonary fibrosis that is likely to result in the subject's death or increases the risk of death within a year from signing the ICF.
• Known clinical diagnosis of pulmonary arterial hypertension that currently requires treatment.
• Subjects with cystic fibrosis, active aspergillosis, active tuberculosis, or other serious concomitant respiratory disorder other than pulmonary fibrosis, as determined by the Investigator. Subjects with reactive airway disease, chronic obstructive pulmonary disease, and asthma may be included as long as, in the opinion of the Investigator, fibrosis is the major contributing factor to the subject's respiratory disorder.
• Use of any cytotoxic agents within 4 weeks of dosing.
• Currently being administered any targeted therapy for pulmonary fibrosis and not on a stable dose for ≥ 6 weeks duration prior to first study dosing (potential subjects should be excluded if a dose increase is planned during the study period).
• Use of Esbriet® (pirfenidone) or Ofev® (nintedanib) within 30 day prior to first dose.
• Currently being administered statins (HMG-CoA reductase inhibitors) and not on a stable dose for ≥ 6 weeks duration prior to first study dosing (potential subjects should be excluded if a dose increase is planned during the study period).
• Taking medications that are substrates of the transporters P-gp, BCRP, OAT3, OATP1B1, OATP1B3, and OCT2 and have a narrow therapeutics index (eg, P-gp substrate digoxin).
• Use of acetaminophen (paracetamol) at a dosage \> 3 grams per day within 2 weeks of first study dosing.
• Use of niacin at a dosage \> 2 grams/day within 2 weeks prior to first study dosing.

Sponsors & Collaborators

• Celgene: lead

Study Sites (6)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

LaPorte County Institute for Clinical Research, Inc

Michigan City, Indiana, 46360, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The Prince Charles Hospital

Chermside, 4032, Australia

Location

St. Vincent's Hospital- Sydney

Darlinghurst, 2010, Australia

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

CC-90001

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ed O'Mara, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 29, 2015
• Study Start: August 5, 2015
• Primary Completion: February 6, 2017
• Study Completion: February 6, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (4); AU (2)