A Study of ELVN-002 in Healthy Adult Volunteers: Part A
- Conditions
- on-small Cell lung cancerNon-small Cell lung cancerCancer - Lung - Non small cell
- Registration Number
- ACTRN12623000440628
- Lead Sponsor
- Enliven Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 34
1. Male or female, aged more than 18 to less than 60 years old (both inclusive at the time of informed consent).
2. In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP at the discretion of the PI or designee.
3. Body mass index (BMI) greater than 18 and less than 32.0 kg/m2 at Screening and weight more than 50 kg.
4. Non-smoker (has not used any tobacco products). A participant who smokes less than 2 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week within 3 months prior to Screening can be included in the study if willing and able to stop smoking for the duration of the study, at the discretion of the PI or designee.
5. Clinical laboratory values at Screening (including haematology, biochemistry, coagulation, and urinalysis) within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
6. Acceptable estimated glomerular filtration rate (eGFR) for the study using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation: greater than 89 mL/min/1.73 for participants 18 to 59 years old, or greater than 84 mL/min/1.73 for participants 60 years old).
7. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1 and be willing to have additional pregnancy tests as required throughout the study.
8. Female participants who meet 1 of the following criteria will be included.
a. Female participants must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after the last study procedure is completed. Females with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Effective forms of contraception include:
• Simultaneous use of intrauterine device (IUD) (non-hormonal) and condom for the male partner.
• Simultaneous use of diaphragm or cervical cap and male condom for the male partner.
• Sterile male partner (vasectomized since at least 6 months prior to first IP administration).
• True abstinence, defined as no sexual intercourse (heterosexual couples). Periodic abstinence and withdrawal are not acceptable methods.
b. Women of non-childbearing potential (WONCBP), defined as postmenopausal for at least more than 12 months, confirmed by follicle stimulating hormone (FSH) levels greater than 40 IU/L, or judged by the Investigator.
9. Male participants must be surgically sterile (more than 90 days since vasectomy with no sperm on sperm analysis; verbal report allowed), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or an acceptable, highly effective contraceptive method must be used from Screening until 90 days after the last study procedure is completed. Effective forms of contraception are shown in Inclusion criterion 7.
Males with same-sex partners (abstinence from penile-vaginal intercourse) or are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least
1. Has participated in previous studies of ELVN-002.
2. Underlying physical or psychological medical condition that, in the opinion of the PI, could impact on the participant’s safety, participant involvement in the study, or data integrity.
3. History or surgical records of any clinically significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary, or gastrointestinal pathology, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the IP, as determined by the PI or designee.
4. History of severe allergic or anaphylactic reactions, or sensitivity to ELVN-002, itraconazole, and phenytoin, or their constituents.
5. History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening (a general practitioner [GP] letter or biopsy report for confirmation required).
6. History of symptomatic bacterial or viral infection within 2 weeks prior to Screening.
7. Abnormal ECG findings at Screening or Day -1 (eg, repeated demonstration of a QTc interval greater than 450 ms (male) or greater than 470 ms (female) corrected by Fridericia's formula [QTcF] or Bazett's formula [QTcB]) that are considered by the PI or designee to be clinically significant.
8. History of clinically significant arrhythmia, cardiac conditions, or risk factors for Torsades de Pointes (eg, heart failure, current hypokalaemia, and family history of long QT syndrome).
9. Clinically significant findings in transthoracic echocardiogram at Screening, including less than normal left ventricular ejection fraction (LVEF).
10. Blood donation or significant blood loss (greater than 500 mL) within 60 days prior to the first administration of IP.
11. Plasma donation within 30 days prior to the first administration of IP.
12. Poor pill swallowing ability.
13. Vaccination with a live vaccine within 1 month prior to the first administration of ELVN-002.
14. Participants who do not have suitable veins for multiple venepunctures/cannulations, as assessed by the Investigator at Screening.
15. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus (HIV) antibody at Screening.
16. Known or suspected history of drug, alcohol, or other substrate abuse within 6 months prior to Screening (verbal confirmation is acceptable).
Regular alcohol consumption defined as greater than 21 units per week for males or greater than 14 units per week for females (where 1 unit equal to 285 mL of beer, 30 mL of spirit, or a 150 mL glass of wine).
17. Positive drugs of abuse screening panel (urine test including but not limited to amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ecstasy (methylenedioxymethamphetamine [MDMA]), methadone, methamphetamines, phencyclidine, opiates, and tetrahydrocannabinol [THC]), or alcohol breath test.
18. Participant is unwilling to abstain from alcohol beginning 48 hours prior to the first administration of ELVN-002.
19. Use of IP or investigational medical device other than the ELVN-002, itraconazole, and phenytoin in this study within 30 days prior to Screening, or 5 half-lives of the product (whichever is the longest).
20. Use of (or anticipated use of) any prescription drugs or the medication leading to prolong the QT/QTc interval for 2 weeks prior to
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method