Phase 1 Study of CC-90005 in Healthy Subjects and Subjects With Moderate to Severe Plaque-type Psoriasis

NCT02502188 | Terminated Phase 1

• 1 other identifier: CC-90005-CP-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of CC-90005 in healthy subjects and subjects with moderate to severe plaque-type psoriasis.

Conditions

Parapsoriasis; Healthy Volunteers

Keywords

Healthy Subjects; Severe Plaque Psoriasis; Moderate; Phase 1; Safety; Tolerability; CC-90005

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse events

  Up to 12 months

Secondary Outcomes (15)

• Pharmacokinetics- Cmax

  Up to 28

• Pharmacokinetics- Tmax

  Up to 28

• Pharmacokinetics- AUC∞

  Up to 28 days

• Pharmacokinetics- AUCt

  Up to 28 days

• Pharmacokinetics- AUC24

  Up to 28 days

Study Arms (2)

Part 1 - CC-90005 and Placebo

EXPERIMENTAL

CC-90005 or Placebo will be administered orally from low to high dose

Drug: CC-90005; Drug: Placebo

Part 2 - CC-90005 and Placebo

EXPERIMENTAL

CC-90005 or Placebo will be administered orally from low to high dose

Drug: CC-90005; Drug: Placebo

Interventions

CC-90005 DRUG

Part 1 - CC-90005 and Placebo; Part 2 - CC-90005 and Placebo

Placebo DRUG

Part 1 - CC-90005 and Placebo; Part 2 - CC-90005 and Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1 (Healthy Subjects)
• Subjects must satisfy the following criteria to be enrolled in the study:
• Female or male subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is in good health as determined by a physical examination at screening.
• Female subjects of childbearing potential (FCBP) 1 must:
• Have two negative pregnancy tests as verified by the Investigator prior to the first dose of Investigational Product (IP). She must agree to ongoing pregnancy testing during the course of the study, and prior to discharge from the clinical site. This applies even if the FCBP subject practices true abstinence from heterosexual contact.
• Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, effective contraception without interruption, during the study (including dose interruptions) and for at least 28 days after discontinuation of IP.
• The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
• Female subjects NOT of childbearing potential must:
• a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening)
• Male subjects must:
• a. Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions and for at least 28 days after discontinuation of IP, even if he has undergone a successful vasectomy.
• Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.

You may not qualify if:

• Part 1 (Healthy Subjects)
• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal (GI), renal, hepatic, CV, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject is pregnant or breastfeeding.
• Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).
• Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days prior to the first dose administration.
• Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration.
• Subject has used CYP3A inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP3A (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
• Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
• Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
• Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
• Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen.
• Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Parapsoriasis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maria Palmisano, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 20, 2015
• Study Start: July 17, 2015
• Primary Completion: November 2, 2015
• Study Completion: November 2, 2015
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (1)