ACTRN12618001417279终止1 期
An Open-Label, Single- and Multiple-Ascending-Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of Extended Release Formulations of ATN 249 in Healthy Male Participants
ifeSci Pharmaceuticals, inc.0 个研究点目标入组 6 人开始时间: 2018年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •1. Male healthy volunteers, age 18 to 55 years, inclusive;
- •2. Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug;
- •3. Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 inclusive;
- •4. Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate;
- •5. Participants must be a non-smoker, and must not have used any tobacco products within two months prior to screening;
- •6. Participant must have no contraindications to consume standard meals provided;
- •7. Participants who have not been sterilized must make a commitment to ensure that their partners (if of child bearing potential) use highly effective contraception during the period from dosing to 7 days post-dose (acceptable forms of contraception are oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system, or abstinence); in addition to these measures, male participants should use a condom for sexual intercourse during this period. This requirement does not apply to participants in same sex relationships;
- •8. Participants must have the ability and willingness to attend the necessary visits to the study center;
- •9. Written informed consent signed prior to entry into the study.
排除标准
- •1. Prior or ongoing medical condition, medical history, physical findings, or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant.
- •2. Previous exposure to ATN-249.
- •3. Mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: Participants who have had situational depression may be enrolled in the study at the discretion of the Investigator or delegate.
- •4. Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
- •5. History of severe allergic or anaphylactic reactions.
- •6. Resting blood pressure greater than 140/90 mm Hg, resting heart rate greater than 90 beats per minute or resting heart rate lower than 50 beats per minute at screening or at Day -1 (repeat measurements are allowed at the discretion of the Investigator. The resting heart rate measurement may be repeated only once if below 50 beats per minute).
- •7. Alkaline phosphatase (ALP), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 1.5 x upper limit of normal at screening. Repeat testing at screening is acceptable for out of range values following approval by the Investigator or delegate.
- •8. Serum potassium lower than 3.7 mmol/L or greater than 5.5 mmol/L at Screening or Day -1. Repeat testing at screening is acceptable for out of range values following approval by the Investigator or delegate.
- •9. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody at screening.
- •10. Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, Tetrahydrocannabinol (THC), amphetamines, benzodiazepines, opiates and cocaine), cotinine test or alcohol breath test.
- •11. Participants with a history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration).
- •12. Regular alcohol consumption defined as greater than 21 alcohol units per week (where 1 unit equal to 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU until completion of the final follow-up visit.
- •13. Participant has left ventricular hypertrophy defined as the combination of the following ECG criteria (both #a and #b must be met):
- •13.a. Voltage criteria (both criteria must be met):
- •13.a.1 S in V1 plus R in V5 or V6 (whichever is larger) greater or equal than 35 mm; and
- •13.a.2 R in aVL greater or equal than 11 mm
- •13.b. Repolarization abnormalities (at least one criteria needs to be met):
- •13.b.1 At least 1mm ST depression (horizontal or down-sloping); or
- •13.b.2 Abnormal T wave inversions
- •14. Participant has other significant ECG abnormalities that might interfere with ECG analysis including evidence of a previous myocardial infarction (MI), flat T waves (particularly in the inferior leads) or more than minor non- specific ST-T wave changes or:
- •14.a. QRS greater than 110 milliseconds (msec),
- •14.b. QT interval corrected using Fridericia’s formula (QTcF) greater than 440 msec,
- •14.c. PR interval greater than 220 msec
- •14.d. Heart rate lower than 50 beats per min
研究者
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