A Study Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-3505 in Healthy Volunteers (PART I).

Phase 1

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12624000990527
• Lead Sponsor: KALLYOPE, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.Must have given written informed consent
2. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions, including following study diet requirements.
3. Be between 18 to 45 years of age, inclusive, at the time of signing informed consent.
4. Have a body mass index (BMI) of 18.5 to 30.0. kg/m2, inclusive.
5. Be a non smoker/non-user of tobacco or other nicotine products, who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 1 month before administration of the initial dose of trial drug, has used no more than 5 tobacco or nicotine forms (eg less than or equal to 5 cigarettes) per week within 3 months of screening, and agrees to abstain from smoking tobacco or the use of nicotine-containing products throughout study participation (through completion of the Poststudy visit).
6. Be judged to be in good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug.
7. Dark-adapted pupil diameter (measured with pupillometer after greater than or equal to 5 minutes at approximate 5 lux) is between 5.0 mm and 8.5 mm in both eyes, and the difference in pupil diameter between the right and left eyes is less than 0.4 mm. Pupil diameter will be measured in triplicate. The middle (median) value for each eye will be used to assess eligibility.
8. Screening ophthalmic exam performed by an ophthalmologist or similarly licensed professional (including assessment of visual acuity, visual fields, intra-ocular pressure, and fundoscopy) identifies no clinically significant abnormalities. Note: Routine refractive errors are not exclusionary, with the exception of myopia with refractive error greater than -3D
9. Meet the following requirements:
a. Is a male who agrees to all of the following:
• To use an appropriate method of contraception, including a condom, from the first dose of study drug until greater than or equal to 90 days after the last dose of study drug. A male participant who had a vasectomy procedure must follow the same restrictions as a non-vasectomized male. This requirement is waived for male participants with male partners.
• To not donate sperm from the first dose of study drug until greater than or equal to 90 days after the last dose of study drug.
OR
b. Is a pre-menopausal female (confirmed via screening follicle stimulating hormone [FSH] test) who is of reproductive potential or surgically sterile due to hysterectomy or bilateral salpingectomy and:
• agrees to not donate eggs from the first dose of study drug for greater than or equal to 30 days after the last dose of study drug AND
• agrees to remain abstinent from heterosexual activitya from Screening through greater than or equal to 30 days after the last dose of study drug OR
• agrees to use (or have their partner use) a birth control method that is highly effective and has low user dependency from Screening through greater than or equal to 30 days after the last dose of study drug. Acceptable methods of birth control are:
- Progestogen-only implant (e.g. etonogestrel implant)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
a Abstinence can be used as the sole method of contraception if it is in line w

Exclusion Criteria

1. Has participated in another investigational study within the following time period: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer or based on local regulations) prior to the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study.
2. Is an employee of the Sponsor or study site or immediate family member (eg, spouse, parent, child, sibling) of the Sponsor or study site.
3. Has a history of multiple significant and/or any severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
4. Has a known hypersensitivity or contraindication to any component of K-3505, its excipients or related compounds.
5. Has a positive alcohol or drug screen at Screening and admission.
6. Has a positive pregnancy test at Screening and Period 1 Day -1.
7. Is a lactating/nursing female.
8. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody, at the Screening Visit. Note: Subjects with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
9. Has a fever at screening* or has a positive COVID-19 test or a fever at Period 1 Day -1.
10. Had major surgery or donated or lost 1 unit of blood or blood products (approximately 500 mL) within 4 weeks prior to Period 1 Day -1.
11. Is unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication and through the completion of study participation at the Follow-Up visit. Exceptions are noted below..
12. Has excessive consumption of alcohol within 6 months prior to screening (greater than 14 drinks/week for males and greater than 7 drinks/week for females, where l drink is equal to 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening.
12. Is unwilling or unable to refrain from study alcohol restrictions:
- Subjects must not consume any alcohol from 3 days (at least 72 hours) prior to check-in through discharge from the unit in each period, and from 3 days (at least 72 hours) prior to the poststudy visit.
- At all other times, alcohol consumption is limited to not more than 14 drinks per week for males and not more than 7 drinks per week for females where l drink is equal to 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor.
13. Is unable or unwilling to refrain from consuming caffeinated products from 24 hours prior to check-in through discharge from the unit in each period, and 24 hours prior to the follow up visit.
14. Has a substance abuse disorder.
15. Had a previous major psychotic disorder.
16. Has a corrected QT interval to Fridericia's formula (QTcF) greater than 450 milliseconds (msec) for males and greater than 470 msec for female

Study & Design

• Study Type: Interventional
• Study Design: Not specified