Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects
NCT ID: NCT04505397
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
111 participants
INTERVENTIONAL
2020-02-13
2022-10-27
Brief Summary
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Detailed Description
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Part A Primary Objective: To evaluate the safety and tolerability of single oral ascending doses of SKL24741 administered to healthy male subjects
Part A Secondary Objectives:
* To evaluate the PK of SKL24741 (R-enantiomer), SKL24742 (S-enantiomer) (if appropriate), and its possible metabolites (if deemed necessary) following administration of single oral ascending doses of SKL24741 administered to healthy male subjects
* To assess the food effect on the PK of SKL24741 and SKL24742 (if appropriate) following administration of a single oral dose of SKL24741 administered to healthy male subjects
* To assess the gender effect on the PK of SKL24741 and SKL24742 (if appropriate) following administration of a single oral dose of SKL24741 administered to healthy female subjects
Part A Exploratory Objective: To assess the formulation effect on the PK of SKL24741 and SKL24742 (if appropriate) following administration of a single oral dose of SKL24741 administered to healthy male subjects
Part B Primary Objective: To evaluate safety and tolerability of multiple oral ascending doses of SKL24741 administered for 14 days to healthy male subjects
Part B Secondary Objective: To evaluate the PK of SKL24741, SKL24742 (if appropriate), and its possible metabolites (if deemed necessary) following administration of multiple oral ascending doses of SKL24741 administered to healthy male subjects
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Single Ascending Dose Level 1
4 Subjects will receive one dose of 10 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 2
4 Subjects will receive one dose of 25 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 3
4 Subjects will receive one dose of 50 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 4
4 Subjects will receive one dose of 100 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 5
4 Subjects will receive one dose of 200 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 6
4 Subjects will receive one dose of 300 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 7
4 Subjects will receive one dose of 400 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 8
4 Subjects will receive one dose of 800 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 9
4 Subjects will receive one dose of 1200 mg and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Single Ascending Dose Level 10
4 Subjects will receive one dose on the outcome of preceding dose levels and 2 subjects will receive one dose of placebo
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 1
6 Subjects will receive one dose of 50 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose).
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 2
6 Subjects will receive one dose of 200 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 3
6 Subjects will receive one dose of 400 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 4
6 Subjects will receive one dose of 800 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 5
6 Subjects will receive one dose of 1200 mg each day for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 6
6 Subjects will receive one dose of 1200 mg each day (using tablet formulation instead of capsule formulation\*) for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
\*Tablet formulation is utilized, instead of capsule formulation, in the marked dose levels.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Food Effect Cohort
After completing the fasting Single Ascending Dose escalation, the same 6 subjects who received one dose of 50 mg under fasting conditions will return to the clinic after a washout period for a second confinement to receive a second dose (same as fasting) under fed conditions.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Gender Effect Cohort
6 female subjects of non-childbearing potential will receive one dose of 50 mg under fasting conditions.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Optional Food Effect Cohort
Up to 12 male subjects will undergo an open-label, two period, two-sequence crossover design at the maximum daily dose tested in Part A.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Optional Formulation Effect Cohort
Up to 12 male subjects will be treated with the maximum daily dose tested in Part A using open-label, two period, two-sequence crossover design.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Multiple Ascending Dose Level 7
6 Subjects will receive one dose of 2000 mg each day (using tablet formulation instead of capsule formulation\*) for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
\*Tablet formulation is utilized, instead of capsule formulation, in the marked dose levels.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Multiple Ascending Dose Level 8
6 Subjects will receive one dose each day (using tablet formulation instead of capsule formulation\*) for 14 days and 2 subjects will receive one dose placebo every day for 14 days. The dose will be determined based on the outcome of Part A (Single Ascending Dose) and/or preceding dose levels of Part B (Multiple Ascending Dose).
\*Tablet formulation is utilized, instead of capsule formulation, in the marked dose levels.
SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Interventions
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SKL24741
An inhibitor of voltage-gated sodium channels and a possible activator of Big Potassium channels. Administered as an oral dose in the form of a capsule or tablet.
Placebo
Sugar pill manufactured to mimic SKL24741
Eligibility Criteria
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Inclusion Criteria
2. Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening
3. Agree to use 2 highly effective methods of contraception, including at least one barrier method (Section 10.6.7 for details)
4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening
5. Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology)
6. Normal electrocardiogram (ECG) (12-lead), arterial blood pressure, and heart rate within the normal range of the study center or considered not clinically significant by the investigator and in agreement with the Sponsor
7. Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned
8. For Part A (gender effect cohort): Female of non-childbearing potential (18 to 50 years of age (inclusive)), who have undergone a sterilization procedure at least 6 months prior to dosing with official documentation (e.g., hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy), or be postmenopausal with amenorrhea for at least 1 year prior to dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per Principal Investigator's judgment
Exclusion Criteria
2. Smokers (subjects who have smoked within 6 months at screening or those with positive results from smoking screening).
3. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair).
4. Regular treatment with prescription medications. Subjects should have ended any prescription medications at least 14 days before the first dosing of the study drug. Potential subjects should only stop any prescribed medication at the direction of a physician.
5. Regular treatment with nonprescription medications. Subjects should have ended any nonprescription medications at least 14 days before the first dosing of the study drug. Potential subjects should consult a physician before stopping any regular treatment with nonprescription medication.
6. Consumption of herbal medications, dietary supplements, and specific fruit products. Subjects should have stopped consumption of herbal medications or dietary supplements (e.g., St. John's Wort, ginkgo biloba, and garlic supplements), vitamins, and grapefruit or grapefruit juice, or Seville oranges at least 14 days before the first dosing of study drug.
7. History of drug or alcohol abuse or addiction within 2 years before the start of study drug dosing, or a positive test results for alcohol or drugs of abuse, such as amphetamine, barbiturate, benzodiazepine, cocaine, methadone, opiates, oxycodone, phencyclidine, propoxyphene, cannabinoid (THC), MDMA (Ecstasy), methaqualone, and tricyclic antidepressant (TCA).
8. Regular consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint \[473 mL\] of beer or lager, 1 glass \[125 mL\] of wine, 25 mL shot of 40% spirit) before screening. Subjects may not consume any alcohol from 72 hours before the first dosing of study drug through the completion of the last PK sampling.
9. Consumption of an average of more than 5 servings (8 ounces per serving) per day of coffee, cola, or other caffeinated beverage before screening. Subjects may not consume any caffeinated beverages from 48 hours prior to dosing until the collection of the last PK sample.
10. Participation in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 7 half-lives (whichever is longer) before screening.
11. Blood donation or a significant loss of blood within 60 days of the start of study drug dosing or donation of more than 1 unit of plasma within 7 days before screening.
12. Positive result at screening for any of the following infectious disease tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antigen and antibody (HIV Ag, HIV Ab)
13. Illness within 5 days before the start of study drug dosing ("illness" is defined as an acute \[serious or non-serious\] condition \[e.g., the flu or the common cold\])
14. History of any known relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
15. Subject who is judged not eligible for study participation by investigator
18 Years
50 Years
ALL
Yes
Sponsors
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Spaulding Clinical Research LLC
OTHER
Covance
INDUSTRY
SK Life Science, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vijaykumar Vashi, PhD
Role: STUDY_DIRECTOR
SK Life Science, Inc.
Locations
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Spaulding Clinical Research
West Bend, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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SKL24741C001
Identifier Type: -
Identifier Source: org_study_id