ACTRN12623000300673已完成1 期
A phase 1, first in human study to assess the pharmacokinetics of single oral doses of PTC607 in the fasted and fed states and to evaluate the comparative bioavailability of 2 formulations of PTC607 in healthy volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Males and females aged 18 to 65 years inclusive at Screening
- •2. Participants able to provide informed consent
- •3. Body mass index of greater than or equal to 18.5 and less than or equal to 30.0 kg/m2 with a body weight of greater than or equal to 50.0 kg for male
- •participants and a body weight of greater than or equal to 45.0 kg for female participants at Screening
- •4. Generally healthy as determined by the investigator based on medical evaluation, including medical history, physical examination, laboratory test results, ECG, and vital signs.
- •5. Male participants must be willing to use 2 acceptable contraceptive methods for the duration of the study and for a minimum of 6 months after the last dose, and female participants of childbearing potential must be willing to use 2 acceptable contraceptive methods for the duration of the study and for a minimum of 30 days after the last dose.
- •6. All female participants of childbearing potential must have a negative serum pregnancy
- •test result at Screening and a negative urine pregnancy test on Day -1.
- •7. Male participants must agree to not donate sperm for the duration of the study and for at
- •least 6 months after the last dose.
- •8. Participants must be willing and able to consume the entire high-fat breakfast in the designated timeframe. Participants with allergies or with vegetarian or vegan lifestyle choices that would prevent them from eating these breakfasts will be excluded.
排除标准
- •1. Participants that participated in any drug or device clinical investigation within 60 days
- •prior to Screening or who anticipate participating in any drug or device clinical
- •investigation within the duration of this study.
- •2. Prior or ongoing medical condition (eg, concomitant illness, psychiatric condition),
- •medical history, and/or physical findings that, in the investigator’s opinion, could
- •adversely affect the safety of the participant or could impair the assessment of study
- •3. An abnormal general neurological examination.
- •4. Presence of any clinically significant abnormality during Screening.
- •5. Any psychological or emotional problems, any disorders, or resultant therapy that is
- •likely to invalidate informed consent or limit the ability of the participant to comply with
- •the protocol requirements.
- •6. A positive hepatitis B surface antigen, positive hepatitis C antibody, or HIV antibody
- •result at Screening.
- •7. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
- •volume drawn at Screening or menses) of 50 to 499 mL within 30 days or more than
- •499 mL within 56 days prior to dosing.
- •8. Excessive alcohol consumption (regular alcohol intake greater than or equal to 21 units per week for male
- •participants and greater than or equal to 14 units per week for female participants) within 6 months prior to
- •Screening. One unit (8 g) is equivalent to a half pint (280 mL) of beer, 1 measure
- •(25 mL) of spirits, or 1 small glass (125 mL) of wine.
- •9. The participant is a smoker or uses other nicotine-containing products. Ex-smokers must
- •have ceased smoking >3 months prior to Screening. Smokers who consume <4 tobacco
- •products per week are allowed.
- •10. The participant has consumed grapefruit (or its juice), star fruit, pomegranate, pomelo,
- •tangelo, or Seville orange-containing products in the 1 week before Screening.
- •11. A positive urine drug screen, cotinine screen, or alcohol breath test at Screening or on
- •Day -1 of each treatment period.
- •12. Females who are pregnant or nursing.
- •13. Participant has previously received PTC607.
研究者
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