The study will evaluate the pharmacokinetics (PK) of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants.
This is a single-group study with a duration of up to 8 weeks (maximum of 53 days) including Screening, Period 1, Period 2, Period 3 and Follow-up. The study will comprise of: * A screening period of 27 days * Three treatment periods: Period 1 (Day -1 to Day 3): Single dose AZD6793 will be administered on Day 1 followed by a 3-day washout period; Period 2 (Day 4 to Day 7): Itraconazole will be administered from Day 4 through Day 7, starting with 2 doses of 200 mg itraconazole given 12 hours apart on Day 4, then 200 mg itraconazole will be given once a day on Day 5 through Day 7. Period 3 (Day 8 to Day 11): On Day 8, participants will be co-administered with AZD6793 and 200 mg itraconazole. Administration of 200 mg itraconazole will continue on Day 9 and Day 10. Participants will be discharged from the clinic on Day 11. * A Follow-up Visit 10-15 days after the last itraconazole dose in Period 3.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
17
Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3.
Participants will receive 2 doses of itraconazole on Day 4 and single dose from Day 5 to Day 7 in Period 2. On Day 8 participants will receive single dose of itraconazole combined with AZD6793 and then single dose of itraconazole from Day 9 to Day 10 in Period 3.
Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3.
Research Site
Berlin, Germany
Maximum plasma drug concentration (Cmax)
The effect of itraconazole on the single-dose Cmax of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The effect of itraconazole on the single-dose AUClast of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The effect of itraconazole on the single-dose AUCinf of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Apparent total body clearance (CL/F)
The effect of itraconazole on the single-dose CL/F of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Terminal elimination half-life (t1/2λz)
The effect of itraconazole on the single-dose t1/2λz of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Time to reach maximum observed concentration (tmax)
The effect of itraconazole on the single-dose tmax of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Apparent volume of distribution during the terminal phase (Vz/F)
The effect of itraconazole on the single-dose Vz/F of AZD6793 will be evaluated in healthy participants.
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Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Ratio Area under plasma concentration-time curve from time 0 to infinity (RAUCinf)
The effect of itraconazole on the single-dose RAUCinf of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Ratio Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (RAUClast)
The effect of itraconazole on the single-dose RAUClast of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Ratio Maximum plasma drug concentration (RCmax)
The effect of itraconazole on the single-dose RCmax of AZD6793 will be evaluated in healthy participants.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
Number of participants with adverse events
The safety and tolerability after administration of AZD6793 with itraconazole will be evaluated.
Time frame: From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose)