Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05284890 | A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants | PHASE1 | COMPLETED | 8 | — | — | May 12, 2022 | Jul 11, 2022 | Dec 1, 2022 | 1 | United States |
| NCT04958291 | Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-99677 in Healthy Adult Japanese Participants. | PHASE1 | COMPLETED | 25 | — | — | Aug 3, 2021 | Dec 7, 2021 | Nov 4, 2022 | 2 | United States |
| NCT04718636 | A Study to Evaluate Effects of CC-99677 on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Participants | PHASE1 | COMPLETED | 28 | — | — | Sep 30, 2020 | Aug 3, 2021 | Oct 28, 2021 | 3 | United States |
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
The area under the curve (AUC) for the defined interval between doses (TAU)
The area under the curve (AUC) from the time of dosing to the last measurable concentration
Maximum observed plasma concentration occurring at Tmax
The time of maximum observed concentration sampled during a dosing interval
Terminal half-life
The total body clearance for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration
The volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero concentration
| Arm | Type | Description |
|---|---|---|
| CC-99677 | EXPERIMENTAL | - |
| Administration of Dose A of CC-99677 or Placebo | EXPERIMENTAL | Administration of Dose A of CC-99677 or Placebo |
| Administration of Dose B of CC-99677 or Placebo | EXPERIMENTAL | Administration of Dose B of CC-99677 or Placebo |
| Administration of Dose C of CC-99677 or Placebo | EXPERIMENTAL | Administration of Dose C of CC-99677 or Placebo |
| Administration of OC alone, then progress to OC in combination with CC-99677 | EXPERIMENTAL | Oral Contraceptive (OC) and CC-99677 will be administered daily |
| Name | Type | Description |
|---|---|---|
| CC-99677 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Placebo |
| Oral Contraceptive (Ortho Tri-Cyclen or its generic equivalent) | DRUG | Daily |
Inclusion Criteria: * Healthy male participants * Body mass index of 18.0 to 33.0 kg/m\^2, inclusive Exclusion Criteria: * Any significant acute or chronic medical illness * Any major surgery within 4 weeks of intervention administration * History of any significant drug allergy Other protocol-d...