NCT06494644

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

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy Participants

Interventions

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

Timeline

• Start date: 2024-07-23
• Primary completion: 2024-10-05
• Completion: 2024-10-05
• First posted: 2024-07-10
• Last updated: 2025-05-31

Locations

1 site across 1 country: Germany