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

Phase 1

• Conditions: Migraine; Neurological - Other neurological disorders

• Registration Number: ACTRN12624001026516
• Lead Sponsor: KALLYOPE, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

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 nonsmoker/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 trialdrug, has used no more than 5 tobacco or nicotine forms (eg less than or equal to 5 cigarettes) per weekwithin 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 laboratorysafety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed atthe 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 approximately 5lux) is between 5.0 mm and 8.5 mm in both eyes, and the diff erence in pupil diameter between the rightand 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 fi elds, intra-ocular pressure, and fundoscopy) identifi es noclinically signifi cant abnormalities. Note: Routine refractive errors are not exclusionary, with the exceptionof myopia with refractive error greater than or equal to 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 fi rst 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 mustfollow the same restrictions as a non-vasectomized male. This requirement is waived for male participantswith male partners.
• To not donate sperm from the fi rst 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 (confi rmed via screening follicle stimulating hormone [FSH] test) who is ofreproductive 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 eff ective and has low userdependency 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 l

Exclusion Criteria

1. Has participated in another investigational study within the following time period: 30 days, 5 half-lives ortwice the duration of the biological eff ect of the investigational product (whichever is longer or based onlocal regulations) prior to the Screening Visit. The window will be derived from the date of the last studyprocedure and/or AE related to the study procedure in the previous study to the Screening Visit of thecurrent 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 signifi cant and or any severe allergies (eg, food, drug, latex allergy) or has hadan anaphylactic reaction or signifi cant intolerance to prescription or nonprescription drugs or food.
4. Has a known hypersensitivity or contraindication to any component of K-3505, fezolinetant (Part II only),their 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 humanimmunodefi ciency antibody, at the Screening Visit. Note: Subjects with positive hepatitis B virus or hepatitisC virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitisC 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 4weeks prior to Period 1 Day -1.
11. Is unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal anddietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzymeinducer) or 5 half-lives (whichever is longer) prior to the fi rst dose of study medication and through thecompletion 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 1 drink is equal to 5 ounces [150 mL] of wine or 12ounces [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.
13. 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 throughdischarge 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 less than or equal to 14 drinks/week for males and less than or equal to 7 drinks/week for females where l drink equal to 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] ofhard liquor.
14. Is unable or unwilling to refrain from consuming caffeinated products from 24 hours prior to check-inthrough discharge from the unit in each period, and 24 hours prior to the follow up visit.
15. Has a substance abuse disorder.
16. Had a previous major psychotic disorder.
17. Has a corrected QT interval to Fridericia's formula (QTcF) greater than 450 milliseconds (msec) for malesand greater t

Study & Design

• Study Type: Interventional
• Study Design: Not specified