NCT04734275

Brief Summary

This study will be a randomised, open-label, 3-period, 3-treatment, single-dose, crossover study in healthy subjects The study will be performed at a single study centre in the United Kingdom.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
Last Updated

December 6, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

January 28, 2021

Last Update Submit

December 3, 2021

Conditions

Chronic Kidney Disease

Keywords

AZD5718Bioavailability5-lipoxygenase activating protein (FLAP) inhibitorSafety and tolerability

Outcome Measures

Primary Outcomes (8)

  • Area under plasma concentration-time curve from zero to infinity (AUCinf) (Treatment A versus Treatment C)

    Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUCinf will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUClast) (Treatment A versus Treatment C)

    Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using AUClast will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • Maximum observed plasma (peak) drug concentration (Cmax) (Treatment A versus Treatment C)

    Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using Cmax will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • Plasma concentration at 24h post-dose (C24) (Treatment A versus Treatment C)

    Relative bioavailability (Frel) of the Test Formulation in the fasted state (Treatment A) compared to Reference Formulation in the fasted state (Treatment C) using C24 will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • AUCinf (Treatment B versus Treatment A)

    Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUCinf will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • AUClast (Treatment B versus Treatment A)

    Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using AUClast will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • C24 (Treatment B versus Treatment A)

    Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using C24 will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

  • Cmax (Treatment B versus Treatment A)

    Relative bioavailability (Frel) of Treatment B (fed state, Test Formulation) versus Treatment A (fasted state, Test Formulation) using Cmax will be assessed.

    Days 1, 2 and 3 of each Treatment Period (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours)

Secondary Outcomes (1)

  • Number of subjects with adverse events (AEs) and serious AEs

    From screening (SAEs only) until Follow-up Visit (5 to 7 days post final dose)

Study Arms (3)

Treatment A (Test Formulation): AZD5718 Dose A, fasted

EXPERIMENTAL

Subjects will receive single dose of AZD5718 (Dose A), in fasted condition.

Drug: AZD5718

Treatment B (Test Formulation): AZD5718 Dose A, fed

EXPERIMENTAL

Subjects will receive single dose of AZD5718 (Dose A) in fed condition

Drug: AZD5718

Treatment C (Reference Formulation): AZD5718 Dose A, fasted

ACTIVE COMPARATOR

Subjects will receive single dose of AZD5718 (Dose A) in fasted condition

Drug: AZD5718

Interventions

AZD5718DRUG

Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions.

Treatment A (Test Formulation): AZD5718 Dose A, fastedTreatment B (Test Formulation): AZD5718 Dose A, fedTreatment C (Reference Formulation): AZD5718 Dose A, fasted

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Healthy male and/or female subjects aged 18 - 55 years inclusive with suitable veins for cannulation or repeated venipuncture.
  • Females must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at each admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at the Screening Visit.
  • Male subjects must adhere to the contraception methods as detailed in protocol.
  • Have a body mass index between 18.5 and 30 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
  • History of any clinically significant disease or disorder which, in the opinion of the principal investigator (PI), may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
  • Any clinically significant abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results, at the Screening Visit and/or on admission to the Clinical Unit for Treatment Period 1 as judged by the PI including:
  • Alanine aminotransferase \> upper limit of normal (ULN)
  • Aspartate aminotransferase \> ULN
  • Bilirubin (total) \> ULN
  • Gamma glutamyl transferase \> ULN
  • Any clinically significant abnormal findings in vital signs and 12-lead electrocardiogram at the Screening Visit and/or on each admission to the Clinical Unit, as judged by the Principal Investigator (PI).
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
  • Any positive result on screening for IgM. If positive for IgG, a reverse transcriptase polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 must be performed on the same day and if positive, the subject is excluded.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

AZD5718

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pablo Forte Soto, Dr

    Parexel Early Phase Clinical Unit London, Level 7, Northwick Park Hospital Watford Road, Harrow Middlesex HA1 3UJ UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

February 1, 2021

Primary Completion

March 25, 2021

Study Completion

March 25, 2021

Last Updated

December 6, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

GB(1)