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Treatment Arm A: High dose for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up midazolam: period 1 (day 1), and period 4 (day 15); rosuvastatin and digoxin: period 2 (day 2), period 3 (days 6 - 14), and period 5 (days 16 - 18)
Awards & highlights

Study Summary

This study will assess the effect of multiple doses of AZD5462 on the PK of oral midazolam (CYP3A4 probe), rosuvastatin (OATP1B1/3, BCRP probe), and digoxin (P-gp probe) in healthy participants. This study will consist of 2 treatment arms (Treatment Arms A and B) and within each treatment arm, the participants will first be administered the probe substrates (midazolam, rosuvastatin, and digoxin) alone followed by administration of the probe substrates together with AZD5462. The treatment arms differ in the dose of AZD5462 being administered and will be performed sequentially starting with Treatment Arm A (AZD5462 Dose A, high dose treatment arm) and followed by Treatment Arm B (AZD5462 Dose B, low dose treatment arm). Each treatment arm will include 5 periods. Thirty two participants in total (16 participants per treatment arm) will be enrolled to ensure at least 24 evaluable participants (12 participants per treatment arm) at the end of the last treatment period. A follow-up visit at Day 24 (+-1 Day) will be conducted via a phone call.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~midazolam: period 1 (day 1), and period 4 (day 15); rosuvastatin and digoxin: period 2 (day 2), period 3 (days 6 - 14), and period 5 (days 16 - 18)
This trial's timeline: 3 weeks for screening, Varies for treatment, and midazolam: period 1 (day 1), and period 4 (day 15); rosuvastatin and digoxin: period 2 (day 2), period 3 (days 6 - 14), and period 5 (days 16 - 18) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-versus-time curve from pre-dose (time 0) extrapolated to infinite time (AUCinf)
Area under the concentration-versus-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUClast)
Secondary outcome measures
Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t1/2λz)
Incidence of Adverse Events (AEs)
Maximum observed serum (peak) drug concentration [Cmax]
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Arm B: Low doseExperimental Treatment4 Interventions
Participants will receive the IMP, AZD5462 Dose B starting on Day 6 and continued until Day 18 and the following approved medicinal products: Midazolam Rosuvastatin Digoxin
Group II: Treatment Arm A: High doseExperimental Treatment4 Interventions
Participants will receive the Investigational Medicinal Product (IMP), AZD5462 Dose A starting on Day 6 and continued until Day 18 and the following approved medicinal products: Midazolam Rosuvastatin Digoxin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digoxin
FDA approved
Midazolam
FDA approved
Rosuvastatin
FDA approved
AZD5462
2022
Completed Phase 1
~150

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ParexelIndustry Sponsor
303 Previous Clinical Trials
101,024 Total Patients Enrolled
AstraZenecaLead Sponsor
4,268 Previous Clinical Trials
288,612,446 Total Patients Enrolled

Frequently Asked Questions

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~12 spots leftby Apr 2025