The primary purpose of this study is to assess potential drug-drug interactions of E2086 when coadministered orally with Itraconazole, Carbamazepine, Midazolam, Dextromethorphan, Bupropion, or Combined Oral Contraceptives in Healthy Participants
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Specified dose on specified days
PPD Austin Clinical Research Unit (CRU)- Phase 1
Austin, Texas, United States
Part A, area under concentration versus time curve from zero time (predose) to time of last quantifiable concentration AUC(0-t) of E2086 and its Metabolite M1
Time frame: Day 1 to Day 4; Day 7 to Day 13
Part A, area under concentration versus time curve from zero time (predose) to infinite time AUC(0-inf) of E2086 and its Metabolite M1
Time frame: Day 1 to Day 4; Day 7 to Day 13
Part A, maximum observed concentration (Cmax) of E2086 and its Metabolite M1
Time frame: Day 1; Day 7
Part B, AUC(0-t) of midazolam (MDZ)
Time frame: Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-t) of dextromethorphan (DEX)
Time frame: Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-t) of bupropion (BUP)
Time frame: Day 4 to Day 8; Day 18 to Day 22
Part B, AUC(0-t) of hydroxybupropion
Time frame: Day 4 to Day 8; Day 18 to Day 22
Part B, AUC(0-inf) of MDZ
Time frame: Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-inf) of DEX
Time frame: Day 1 to Day 4; Day 15 to Day 18
Part B, AUC(0-inf) of BUP
Time frame: Day 4 to Day 8; Day 18 to Day 22
Part B, AUC(0-inf) of hydroxybupropion
Time frame: Day 4 to Day 8; Day 18 to Day 22
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Part B, Cmax of MDZ
Time frame: Day 1 and Day 15
Part B, Cmax of DEX
Time frame: Day 1 and Day 15
Part B, Cmax of BUP
Time frame: Day 4 and Day 18
Part B, Cmax of hydroxybupropion
Time frame: Day 4 and Day 18
Part C, AUC(0-t) of ethinyl estradiol (EE)
Time frame: Day 1 to Day 5; Day 12 to Day 16
Part C, AUC(0-t) of norethindrone (NET)
Time frame: Day 1 to Day 5; Day 12 to Day 16
Part C, AUC(0-inf) of EE
Time frame: Day 1 to Day 5; Day 12 to Day 16
Part C, AUC(0-inf) of NET
Time frame: Day 1 to Day 5; Day 12 to Day 16
Part C, Cmax of EE
Time frame: Day 1; Day 12
Part C, Cmax of NET
Time frame: Day 1 and Day 12
Part A, Number of Participants With Treatment-emergent Adverse Events (TEAEs) for single or multiple doses of E2086, ITZ, and CBZ
Time frame: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
Part A, Number of Participants With Abnormal Laboratory Parameter Values for single or multiple doses of E2086, ITZ, and CBZ
Time frame: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
Part A, Number of Participants With Clinically Significant Change in Vital Sign Values for single or multiple doses of E2086, ITZ, and CBZ
Time frame: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
Part A, Number of Participants With Clinically Significant Change in 12-Lead Electrocardiogram (ECG) Values for single or multiple doses of E2086, ITZ, and CBZ
Time frame: ITZ: Baseline up to Day 13; CBZ: Baseline up to Day 18
Part B, Number of Participants With TEAEs for single or multiple doses of E2086, MDZ, DEX, or BUP
Time frame: Baseline up to Day 24
Part B, Number of Participants With Abnormal Laboratory Parameter Values for single or multiple doses of E2086, MDZ, DEX, or BUP
Time frame: Baseline up to Day 24
Part B, Number of Participants With Clinically Significant Change in Vital Sign Values for single or multiple doses of E2086, MDZ, DEX, or BUP
Time frame: Baseline up to Day 24
Part B, Number of Participants With Clinically Significant Change in 12-Lead ECG Values for single or multiple doses of E2086, MDZ, DEX, or BUP
Time frame: Baseline up to Day 24
Part C, Number of Participants With TEAEs for coadministration of E2086 and combined oral contraceptive (COC)
Time frame: Baseline up to Day 18
Part C, Number of Participants With Abnormal Laboratory Parameter Values for coadministration of E2086 and COC
Time frame: Baseline up to Day 18
Part C, Number of Participants With Clinically Significant Change in Vital Sign Values for coadministration of E2086 and COC
Time frame: Baseline up to Day 18
Part C, Number of Participants With Clinically Significant Change in 12-Lead ECG Values for coadministration of E2086 and COC
Time frame: Baseline up to Day 18