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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 1, Multicenter, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CC-90005 in Healthy Subjects and Subj

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.

Detailed Summary: This is a 2-part study to be conducted at multiple study centers. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90005 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, baseline phase(s), treatment phase(s) and a follow up visit. There will be a total of 3 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90005 and 2 subjects will receive placebo depending on the randomization schedule. Each cohort will receive a minimum of 2 doses, with one of the cohorts receiving a third dose (up to three study periods per cohort). Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90005 following multiple oral doses in subjects with moderate to severe plaque-type psoriasis. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 4 planned cohorts, each of which will consist of a different dose level, with 12 subjects per cohort. In each cohort, 9 subjects will receive a dose of CC-90005 and 3 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered twice daily for 28 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1 and/or from previous data obtained in Part 2.
Sponsor: Celgene Corporation

Current Primary Outcome: Adverse Events (AEs) [ Time Frame: Up to 12 months ]

Number of participants with adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics- Cmax [ Time Frame: Up to 28 ]
    Maximum observed plasma concentration
  • Pharmacokinetics- Tmax [ Time Frame: Up to 28 ]
    Time to Cmax (Maximum observed plasma concentration)
  • Pharmacokinetics- AUC∞ [ Time Frame: Up to 28 days ]
    Area under the plasma concentration-time curve from time zero extrapolated to infinity
  • Pharmacokinetics- AUCt [ Time Frame: Up to 28 days ]
    Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
  • Pharmacokinetics- AUC24 [ Time Frame: Up to 28 days ]
    Area under the plasma concentration-time curve from time zero to 24 hours post dose
  • Pharmacokinetics- AUCτ [ Time Frame: Up to 28 days ]
    Area under the plasma concentration-time curve from time zero to tau (τ), where τ is the dosing interval
  • Pharmacokinetics- t1/2 [ Time Frame: Up to 28 days ]
    Terminal elimination half-life
  • Pharmacokinetics- CL/F [ Time Frame: Up to 28 days ]
    Apparent total plasma clearance when dosed orally
  • Pharmacokinetics- Vz/F [ Time Frame: Up to 28 days ]
    Apparent total volume of distribution when dosed orally, based on the terminal phase
  • Pharmacokinetics- RAc [ Time Frame: Up to 28 days ]
    Ratio of accumulation
  • Quality of Life Analysis [ Time Frame: Up to Day 36 ]
    Dermatology Life Quality Index will be used to assess quality of life throughout study
  • Body Surface Area Involvement [ Time Frame: Up to Day 36 ]
    Standard body surface area grading scale will be used to assess severity of psoriasis throughout study
  • Psoriasis Area and Severity Index Scores [ Time Frame: Up to Day 36 ]
    Standard psoriasis area and severity index scale will be used to assess severity of psoriasis throughout study
  • Static Physicians Global Assessment score [ Time Frame: Up to Day 36 ]
    Static physicians global assessment score will be used to assess severity of psoriasis throughout study
  • Effect of CC-90005 on ECG parameters [ Time Frame: Up to 50 hours ]
    12-lead ECGs will be extracted from continuous Holter recordings and used to assess the effect of CC-90005 on ECG parameters


Original Secondary Outcome: Same as current

Information By: Celgene Corporation

Dates:
Date Received: July 16, 2015
Date Started: July 2015
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016