A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants.

Sponsor
AstraZeneca
Study ID
NCT06494644
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • AZD6793 — DRUG
    Participants will receive single dose of AZD6793 on Day 1 in Period 1 and on Day 8 in combination with itraconazole in Period 3.
  • Itraconazole — DRUG
    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.
  • AZD6793+ Itraconazole — DRUG
    Participants will receive a combined dose of AZD6793 and itraconazole on Day 8 in Period 3.

Study Details

The study will evaluate the pharmacokinetics (PK) of AZD6793 when administered alone and in combination with itraconazole in healthy adult participants.

Key Dates

Start date
Jul 23, 2024
Status verified
May 2025
Primary completion
Oct 5, 2024
Completion
Oct 5, 2024

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: AZD6793 and Itraconazole
    Participants will receive a single dose of AZD6793 on Day 1. On Day 4, the participant will receive 2 doses of 200 mg itraconazole 12 hours apart followed by a single dose of 200 mg itraconazole from Days 5 to 7. On Day 8, participants will receive a combined dose of AZD6793 and 200 mg itraconazole. On Day 9 and Day 10, the participants will receive a single dose of 200 mg itraconazole.

Primary Outcome Measure

Maximum plasma drug concentration (Cmax) [ Time Frame: Post-dose on Day 1 to Day 3; and Day 8 to Day 11 ]

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