An Open-label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect and Dose Proportionality of CC-292 Spray Dried Dispersion Formulation in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics - AUC 0-24
研究概览
简要总结
To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet.
详细描述
This is a single center, open-label, randomized, seven-treatment, seven-period, crossover design. The study will consist of a screening phase, a treatment phase, and a follow-up phone call. Approximately 24 healthy adult subjects (male or female) will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must understand and voluntarily sign a written Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- •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.
- •Must be a male or female subject from any race between 18 to 65 years of age (inclusive) at the time of signing the ICF, and in good health as determined by Physical Examinations (PE).
- •Must comply with the following acceptable forms of contraception:
- •Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception with male condoms NOT made out of natural animal membrane (e.g., latex or polyurethane condoms are acceptable) while on study drug, and for at least 90 days after the last dose of study drug.
- •Females of childbearing potential (FCBP) 1 must have a negative pregnancy test at Screening and at Baseline (i.e., on Day -1). FCBP who engage in activity in which conception is possible must agree to use one of the following forms of contraception during their entire participation in the study and for at least 30 days after administration of the last dose of study drug:
- •Option 1: Any one of the following: non-oral hormonal contraception (e.g., injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or a partner with a vasectomy; OR
- •Option 2: Oral contraceptive pills PLUS one additional barrier method of the following: (a) male or female condom NOT made out of natural animal membrane (e.g., latex or polyurethane is acceptable); (b) diaphragm with spermicide; (c) cervical cap with spermicide; or (d) contraceptive sponge with spermicide; OR
- •Option 3: TWO of the following barrier methods: (a) male or female condom NOT made out of natural animal membrane (e.g., latex or polyurethane is acceptable); (b) diaphragm with spermicide; (c) cervical cap with spermicide; or (d) a contraceptive sponge with spermicide.
- •Note: All other females must have been surgically sterilized for at least 6 months before Screening (proper documentation required), or be postmenopausal (defined as 24 months without menses before Screening, and an estradiol level of < 30 pg/mL and a plasma Follicle Stimulating Hormone (FSH) level > 40 IU/L at Screening).
- •Must have a Body Mass Index (BMI) between 18 and 33 kg/m2 (inclusive).
- •No clinically significant laboratory test results, as determined by the Investigator.
- •Must be afebrile, with supine systolic BP of 90 to 140 mmHg, a supine diastolic Blood Pressure (BP) of 60 to 90 mmHg, and pulse rate of 40 to 110 bpm.
- •Must have a normal or clinically acceptable 12-lead Electrocardiogram (ECG) at Screening. Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.
排除标准
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study.
- •Use of any prescribed systemic or topical medication (including but not limited to antibiotics, analgesics, anesthetics, etc.) prior to 30 days of the first dose administration, unless Sponsor agreement is obtained.
- •Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 7 days of the first dose administration, unless Sponsor agreement is obtained.
- •Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion (e.g., bariatric procedure), or plans to have elective or medical procedures during the conduct of the trial. Subjects post cholecystectomy and post appendectomy may be included.
- •Exposure to an investigational drug within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
- •Donated blood or plasma prior to 4 weeks before the first dose administration to a blood bank or blood donation center.
- •History of multiple drug allergies (i.e., two or more);
- •History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) prior to 2 years before first dose administration, or a positive drug screen reflecting consumption of illicit drugs.
- •History of alcohol abuse (as defined by the current version of the DSM) prior to 2 years before dosing, or a positive alcohol screen.
- •Known to have hepatitis, or known to be a carrier of the Hepatitis B Surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCVAb), or have a positive result to the test for HBsAg, HCVAb, or Human Immunodeficiency Virus (HIV) antibodies at Screening.
- •History of smoking or the use of nicotine containing products prior to 3 months of Screening by self reporting.
- •Female subjects lactating or breastfeeding a child.
研究组 & 干预措施
CC-292 SDD (Spray Dried Dispersion)300mg - Fasted Condition
Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets)
干预措施: CC-292 (Drug)
CC-292 SDD 300mg - Fed Condition
Single oral dose of 300 mg CC-292 SDD under fed conditions (100 mg SDD x 3 tablets)
干预措施: CC-292 (Drug)
375mg P22 - Fasted condition
Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3)
干预措施: CC-292 (Drug)
375mg P22 Fed Condition
Single oral dose of 375 mg P22 under fed conditions (125 mg P22 x 3)
干预措施: CC-292 (Drug)
CC-292 SDD 100 mg Fasted Condition
Single oral dose of 100 mg CC-292 SDD under fasted conditions
干预措施: CC-292 (Drug)
SDD plus OMP (Oral Omeprazole)
Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) in the presence of 40 mg
干预措施: CC-292 (Drug)
SDD plus OMP (Oral Omeprazole)
Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) in the presence of 40 mg
干预措施: Oral Omeprazole (OMP) (Drug)
P22 plus OMP
Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) in the presence of 40 mg oral OMP
干预措施: CC-292 (Drug)
P22 plus OMP
Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) in the presence of 40 mg oral OMP
干预措施: Oral Omeprazole (OMP) (Drug)
结局指标
主要结局
Pharmacokinetics - AUC 0-24
时间窗: 48 hours
Area under the plasma concentration-time curve to 24 hours post dose
Pharmacokinetics - Frel
时间窗: 48 hours
Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation
Pharmacokinetics - λz
时间窗: 48 hours
Terminal disposition rate constant
Pharmacokinetics - Vz/F
时间窗: 48 hours
Apparent volume of distribution
Pharmacokinetics - Cmax
时间窗: 48 hours
Maximum observed concentration in plasma
Pharmacokinetics - %AUCextrap
时间窗: 48 hours
Percent Area under the plasma concentration-time curve extrapolated
Pharmacokinetics - Tmax
时间窗: 48 hours
Time to Cmax
Pharmacokinetics - AUC 0-t
时间窗: 48 hours
Area under the plasma concentration-time curve from time zero to the last measured time point
Pharmacokinetics - AUC 0-∞
时间窗: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Pharmacokinetics - t1/2
时间窗: 48 hours
Terminal half-life
Pharmacokinetics - CL/F
时间窗: 48 hours
Apparent clearance
次要结局
- Adverse Events (AEs)(Approximatly 52 days)