Clinical trial NCT05503511: Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects
Official title: A Single-center, Randomized, Placebo Controlled, Double-blind, Ascending Single-dose and Repeated-dose Trial to Determine the Safety and Pharmacokinetic Profile of NPT 2042 Soft-Gelatin Capsules Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Alzheimer Disease
Epilepsy Intractable
Keywords: CNS Disorder
Seizure Disorder
Lead sponsor: NeuroPro Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.

Detailed description: The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment for patients with medically intractable epilepsy. Prior to evaluating efficacy in the intended patient population, safety and pharmacokinetics of NPT 2042 will be investigated.

Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) of 18 to 32 kg/m2, inclusive
2. A minimum body weight of 50 kg for males and 45 kg for females
3. All females must have a negative serum pregnancy test at Screening and a negative serum pregnancy test upon admission to the clinical research center.
4. Females must be of nonchild-bearing potential defined as permanently sterile (i.e., due to hysterectomy) or postmenopausal (defined as more than one year since last menstrual period).
5. Male subjects with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subjects) plus an additional barrier method (female partner) of contraception for the duration of the study and for at least 90 days after dosing; subjects must also agree to refrain from sperm donation for at least 90 days after their last dose of IP.
6. Able to swallow capsules.

Exclusion Criteria:

1. Presence of active or recurring clinically-significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
2. Presence of an active malignancy or a malignancy of any type within the past five years, other than squamous cell or basal cell carcinoma of the skin.
3. Personal or family history of long QT syndrome.
4. History or evidence of adverse symptoms associated with phlebotomy or blood donation (e.g., prolonged bleeding after injury or shaving, frequent epistaxis or gingival bleeding, bruises easily).
5. History of clinically significant vertigo, dizziness or orthostatic hypotension or any vasovagal syncope or recurrent presyncope in connection with orthostatic challenge.
6. Reported use of or inability to refrain from or anticipated use of during the study

   * any prescription drug within 14 days prior to dosing;
   * any nonprescription drug, nutritional supplement, or vitamin within 7 days prior to dosing; NOTE: acetaminophen is allowed at a dose of ≤2000 mg/day
   * any known enzyme-inducer or enzyme-inhibitor including St. John's Wort within 28 days prior to dosing, or
   * reported chronic exposure to enzyme inducers such as paint solvents or pesticides within 30 days of dosing.
7. Supine blood pressure (BP) less than 80/50 mmHg or greater than 140/90 mmHg.
8. Supine heart rate \<40 bpm and \>90 bpm.
9. History of drug abuse or current use of drugs of abuse or excessive ethanol intake
10. Current Smoking, vaping, hookah, chewing tobacco, or history of smoking/vaping/chewing any substance
11. Average consumption of ≥3 caffeine-containing beverages or xanthine-containing foods per day.
12. Positive urine drug, alcohol, or cotinine result at screening

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 11 days
measure: Number of participants with abnormal lab test results
timeFrame: Up to 11 days
measure: Number of participants with abnormal vital signs
timeFrame: Up to 11 days
measure: Number of participants with abnormal ECG
timeFrame: Up to 7 days
Secondary outcomes:
measure: Pharmacokinetic Cmax
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Pharmacokinetic Tmax
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Pharmacokinetic half-life (t1/2)
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Pharmacokinetic AUClast
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Pharmacokinetic AUCinf
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Pharmacokinetic CL/F
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Pharmacokinetic VzF
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
measure: Dose proportionality
timeFrame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References: