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Treatment C for Healthy Subjects

Phase 1

Waitlist Available

Led By Ronald Goldwater, MD

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 day 1-6, 8-10, 13-15, 17-19

Awards & highlights

Study Summary

This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food (fed state) or without food (fasted state).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1-6, 8-10, 13-15, 17-19

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1-6, 8-10, 13-15, 17-19

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-6, 8-10, 13-15, 17-19 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 concentration time curve from time 0 to infinity (AUCinf)

Area under the concentration time curve from time 0 to the last quantifiable concentration (AUClast)

Maximum observed concentration (Cmax)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Treatment FExperimental Treatment2 Interventions

Subjects will receive a low-fat breakfast 30 minutes before AZD5055 film-coated tablet administered together with rabeprazole on Day 17. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18 in Period 5.

Group II: Treatment EExperimental Treatment2 Interventions

Subjects will receive rabeprazole twice daily on Day 10. On Day 1 (Study Day 13), AZD5055 film-coated tablet will be administered, under fasted conditions, together with rabeprazole and rabeprazole dosing will continue twice daily in Period 4.

Group III: Treatment DExperimental Treatment1 Intervention

Subjects will receive a standardized high-fat breakfast 30 minutes before film-coated tablet of AZD5055 administered as On Day 1 (Study Day 8) in Period 3.

Group IV: Treatment CExperimental Treatment1 Intervention

Subjects will receive AZD5055 film-coated tablet in overnight fasted state on Day 1 (Study Day 4) in Period 2.

Group V: Treatment BExperimental Treatment1 Intervention

Subjects will receive oral suspension of AZD5055 in an overnight fasted state on Day 1 in Period 1.

Group VI: Treatment AExperimental Treatment1 Intervention

Subjects will receive AZD5055 solution as a 20-minute infusion in overnight fasted state on Day 1 in Period 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD5055 solution for infusion

2022

Completed Phase 1

~30

AZD5055 oral suspension

2022

Completed Phase 1

~30

AZD5055 film-coated tablet

2022

Completed Phase 1

~30

Rabeprazole, Delayed-release tablet

2022

Completed Phase 1

~30

Do I qualify?Apply below to find out

Find a Location

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

100,805 Total Patients Enrolled

AstraZenecaLead Sponsor

4,257 Previous Clinical Trials

288,593,765 Total Patients Enrolled

Ronald Goldwater, MDPrincipal InvestigatorPAREXEL Early Phase Clinical Unit Baltimore

13 Previous Clinical Trials

586 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age eligibility for this experiment restricted to any particular range?

"For this medical research, the age requirements are individuals between 18 and 55 years old."

Answered by AI

Has Treatment D been formally accepted by the FDA?

"Because Treatment D is in the early stages of clinical trials, our team at Power has tentatively rated its safety a 1 out of 3. This tentative rating reflects limited data supporting both efficacy and overall safety."

Answered by AI

Are there any available vacancies to join this research endeavor?

"Indeed, the clinicaltrials.gov database indicates that this research is actively enrolling participants at present - with a posting date of November 4th 2022 and an update on November 25th 2022. Currently, 18 individuals are sought from 1 site."

Answered by AI

Is it feasible for me to become a participant in this investigation?

"This clinical trial requires the enrolment of 18 patients that are above legal age and within a healthy range. Those who meet these criteria may qualify for participation in this study."

Answered by AI

How many participants are being examined for this experiment?

"That is correct. Clinicaltrials.gov shows that this medical research project, which was initially posted on November 4th 2022, is presently recruiting individuals to participate in the trial. A total of 18 patients are required for enrollment at one single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.

2022. "A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630677.