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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Fibrosis, Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial ...
    Fibrosis, Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial ...
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: CC-90001, Other: Placebo

Eligibility
  • Ages: 40 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: CC-90001, Other: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Loma Linda Univ Medical Center, Loma Linda, California, United States

Brief Summary

This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

  • Status Active, not recruiting
    Active, not recruiting
  • Condition Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
    Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
  • Phase Phase 2
    Phase 2
INTERVENTION

Drug: CC-90001, Drug: Placebo

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: CC-90001, Drug: Placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Hopital Haut Leveque, Pessac Cedex, France

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001

  • Status Completed
    Completed
  • Condition Healthy Volunteers
    Healthy Volunteers
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: Placebo, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001

Eligibility
  • Ages: 18 to 50 Years (Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001, Drug: Placebo, Drug: CC-90001, Drug: CC-90001, Drug: CC-90001

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

PPD Development, LP, Austin, Texas, United States

Brief Summary

First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001

A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects

  • Status Completed
    Completed
  • Condition Heathy Volunteer
    Heathy Volunteer
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-90001, Drug: Omeprazole, Drug: Midazolam, Drug: Warfarin, Dietary Supplement: Vitamin K, Drug: Rosuvastatin, Drug: Metformin, Drug: Digoxin, Drug: Nintedanib

Eligibility
  • Ages: 18 to 64 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: CC-90001, Drug: Omeprazole, Drug: Midazolam, Drug: Warfarin, Dietary Supplement: Vitamin K, Drug: Rosuvastatin, Drug: Metformin, Drug: Digoxin, Drug: Nintedanib

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Covance Clinical Research Unit, Daytona Beach, Florida, United States

Brief Summary

This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows: - Screening (Days -21 through -2) - Baseline phase for each study period (Periods 1 and 2) - Treatment phase for each study period (Periods 1 and 2) - Follow-up telephone call

A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects

  • Status Completed
    Completed
  • Condition Healthy Volunteer
    Healthy Volunteer
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages: 18 to 64 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Paraxel International, Glendale, California, United States

Brief Summary

This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects. The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).

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

  • Status Completed
    Completed
  • Condition Pulmonary Fibrosis
    Pulmonary Fibrosis
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Tampa General Hospital, Tampa, Florida, United States

Brief Summary

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

Effect of UV Exposure on the PD of Multiple Doses of CC-90001 and Pilot Food Effect Study

  • Status Completed
    Completed
  • Condition Healthy Subjects
    Healthy Subjects
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages: 18 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Covance-Daytona Beach, Daytona Beach, Florida, United States

Brief Summary

This is a two-part, phase 1 study to evaluate the pharmacokinetics and pharmacodynamics of multiple doses of CC-90001 and the effects of food and formulation on the pharmacokinetics of single dose CC-90001 in healthy subjects. Part 1 involves the exposure of subjects to the minimum amount of UV-B light that causes minimally perceptible skin reddening. This will take place before dosing (baseline) and 3 times more while on increasing doses of CC-90001. Punch biopsies of the exposed areas will be taken and assessed for c-Jun terminal kinase activity. Part 2 involves evaluation of changes in pharmacokinetics of 2 formulations of CC-90001 when administered in the fasted state and after a high-fat meal.

A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects

  • Status Completed
    Completed
  • Condition Hepatic Impairment
    Hepatic Impairment
  • Phase Phase 1
    Phase 1
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages: 18 to 70 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
INTERVENTION

Drug: CC-90001

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Miami Miller School of Medicine, Miami, Florida, United States

Brief Summary

This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria.