Anaheim Clinical Trials
Anaheim, California, 92801, United States
NCT Number: NCT03376997
This study will be conducted to evaluate the bioavailability of a single 12 milligram (mg) dose of perampanel intravenous infusions of different durations relative to a single 12 mg dose of perampanel oral tablet in healthy participants.
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Notify Me20 year–55 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. Born in Japan to Japanese parents and grandparents of Japanese descent; ii. Have been living outside Japan for less than 5 years; and iii. Lifestyle, including diet, has not changed significantly since leaving Japan
Exclusion criteria
i. Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
i. Prescription drugs are prohibited within 4 weeks of dosing and over-the-counter (OTC) drugs within 2 weeks before dosing or throughout the Treatment Phase ii. Smoking or use of tobacco or nicotine-containing products is prohibited within 4 weeks before dosing and throughout the Treatment Phase iii. Intake of caffeinated beverages or food is prohibited within 72 hours before dosing and until 72 hours postdose iv. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect Cytochrome P450 (CYP) 3A4 enzyme or transporters (eg, alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [eg, kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard] and charbroiled meats) is prohibited within 2 weeks before dosing and throughout the Treatment Phase v. Intake of herbal preparations containing St. John's Wort is prohibited within 4 weeks before dosing and throughout the Treatment Phase
IV infusion
Other names: E2007
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (Day [D]1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
Cmax is the maximum plasma concentration of a drug after administration. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
AUC is a measure of actual body exposure to drug after administration of the drug. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
AUC is a measure of actual body exposure to drug after administration of the drug. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
AUC is a measure of actual body exposure to drug after administration of the drug. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
tmax is the time to reach maximum concentration following drug administration. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
t1/2 is the time required for the concentration of the drug to reach half of its original value. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
CL is the volume of plasma cleared of drug per unit time. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: predose; 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 12 (D1 and D43); 24 and 36 (D2 and D44); 48 (D3 and D45); 72 (D4 and D46); 120 (D6 and D48); 168 (D8 and D50); 336 (D15 and D57); and 504 (D22 and D64) hours after dosing start
Vd is the apparent volume in which a drug is distributed. Dosing will occur on Day 1 of Treatment Period 1 and Day 43 of Treatment Period 2.
Time frame: Up to approximately 16 weeks
An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (an adverse event [AE] is considered life-threatening if, in the view of either the Investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death.); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
Time frame: Up to approximately 16 weeks
An AE is any untoward medical occurrence and does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product (IP), whether or not related to the IP. AEs include pre-existing conditions that worsen. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
Time frame: Up to approximately 16 weeks
Clinical significance will be determined by the Investigator.
Time frame: Up to approximately 16 weeks
Concomitant medications are medications that started after the date of the first dose of perampanel until the end of the study.
Time frame: Up to approximately 16 weeks
Clinical significance will be determined by the Investigator.
Time frame: Up to approximately 16 weeks
Clinical significance will be determined by the Investigator.
Eisai Inc.
Industry
An Open-Label, Randomized, Crossover Study to Evaluate Bioavailability of a Single 12 mg Dose of Perampanel for Three Intravenous Infusion Durations Relative to a Single 12 mg Perampanel Oral Tablet in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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