Research Site
Berlin, 14050, Germany
NCT Number: NCT06494644
The study will evaluate the pharmacokinetics (PK) of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Berlin, 14050, Germany
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
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.
Time frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11
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
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
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
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
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
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
The effect of itraconazole on the single-dose Vz/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
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
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
The effect of itraconazole on the single-dose RCmax of AZD6793 will be evaluated in healthy participants.
Time frame: From first dose (Day 1) until Follow-up (10-15 days post last itraconazole dose)
The safety and tolerability after administration of AZD6793 with itraconazole will be evaluated.
AstraZeneca
Industry
An Open-label, Single-group, Three-period, Fixed-sequence, Phase I Study to Assess the Pharmacokinetics of AZD6793 Tablets When Administered Alone and in Combination With Itraconazole Capsules in Healthy Adult Female and Male Participants.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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