An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions

Conditions

• Dyslipidaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• AZD0780 — DRUG
  Dose 1 and Dose 2
• Itraconazole — DRUG
  * Period 2 (itraconazole administration only). * Period 3 (AZD0780 + itraconazole administration).
• Carbamazepine — DRUG
  * Period 2 (carbamazepine administration only). * Period 3 (AZD0780 + carbamazepine administration only).
• Midazolam — DRUG
  * Period 1 (midazolam administration only). * Period 3 (AZD0780 + midazolam administration).
• Ethinyl estradiol/levonorgestrel — DRUG
  * Period 1 (EE and LNG administration only). * Period 3 (AZD0780 + EE and LNG administration).

Study Details

An open-label, fixed sequence study in healthy participants to assess the pharmacokinetics of AZD0780 when administered alone and in combination with itraconazole and carbamazepine, and to assess the pharmacokinetics of midazolam and ethinyl estradiol/levonorgestrel (EE and LNG) when administered alone and in combination with AZD0780.

Key Dates

Start date

Sep 25, 2024

Status verified

Apr 2025

Primary completion

Feb 17, 2025

Completion

Feb 17, 2025

Study Design

Enrollment

59 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Arms

• Experimental: Itraconazole Cohort
  * All participants will receive 2 single doses of dose 1 of AZD0780 and 14 doses of itraconazole, under fed conditions. * This part will consist of Period 1 (AZD0780 administration only), Period 2 (itraconazole administration only), and Period 3 (AZD0780 + itraconazole administration).
• Experimental: Carbamazepine Cohort
  * All participants will receive 2 single doses of dose 1 of AZD0780 and 6 doses of 100 mg, 6 doses of 200 mg, and 40 doses of 300 mg carbamazepine, under fed conditions. * This part will consist of Period 1 (AZD0780 administration only), Period 2 (carbamazepine administration only), and Period 3 (AZD0780 + carbamazepine administration)
• Experimental: Midazolam Cohort
  * All participants will receive 10 single doses of AZD0780 dose 2 and 2 doses of midazolam. On midazolam dosing days, participants will receive midazolam under fasted conditions. * This part will consist of Period 1 (midazolam administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + midazolam administration).
• Experimental: EE and LNG Cohort
  * All participants will receive 15 single doses of AZD0780 dose 2 and 2 doses of EE and LNG. On EE and LNG dosing days, participants will receive EE and LNG under fasted conditions. * This part will consist of Period 1 (EE and LNG administration only), Period 2 (AZD0780 administration only), and Period 3 (AZD0780 + EE and LNG administration).

Primary Outcome Measure

AUCinf (Area under concentration-time curve from time 0 to infinity) [ Time Frame: Period 1 (Day 1 to 11 Cohort 1 and Cohort 2) and Period 3 (Day 14-24 Part 1 and Day 27-37 Part 2) ]

Locations (1)

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