A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.

NCT06531811 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: D6830C00002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the potential difference between pharmacokinetics (PK), safety, tolerability and device performance between the AZD8630 test formulation and the AZD8630 reference formulation.

Conditions

Healthy Participants

Keywords

Trehalose/leucine/trileucine/citrate (TLTC); Trehalose/leucine/trileucine/histidine (TLTH); Asthma

Outcome Measures

Primary Outcomes (1)

• Area under the serum concentration-time curve from time zero to the last quantifiable concentration test/Monodose

  To evaluate the relative bioavailability of AZD8630 test device compared to AZD8630 Monodose device.

  From Baseline Day 1 to Day 11

Secondary Outcomes (16)

• Maximum observed plama (peak) drug concentration (Cmax)

  From Baseline Day 1 to Day 11

• Area under the plasma concentration curve from zero to infinity (AUCinf)

  From Baseline Day 1 to Day 11

• Area under the plasma concentration curve from zero to last quantifiable concentration (AUClast)

  From Baseline Day 1 to Day 11

• Time to reach peak or maximum observed concentration or response following drug administration (tmax)

  From Baseline Day 1 to Day 11

• The last time point at which the concentration is measured (tlast)

  From Baseline Day 1 to Day 11

Study Arms (2)

Sequence 1 (Treatment A- Treatment B)

EXPERIMENTAL

Participants will receive Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder)

Drug: AZD8630 (test formulation) via test inhaler; Drug: AZD8630 (reference formulation) via Monodose inhaler; Device: Test inhaler; Device: Monodose inhaler

Sequence 2 (Treatment B- Treatment A)

EXPERIMENTAL

Participants will receive Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder)

Drug: AZD8630 (test formulation) via test inhaler; Drug: AZD8630 (reference formulation) via Monodose inhaler; Device: Test inhaler; Device: Monodose inhaler

Interventions

AZD8630 (test formulation) via test inhaler DRUG

Participants will receive AZD8630 via test inhaler.

Sequence 1 (Treatment A- Treatment B); Sequence 2 (Treatment B- Treatment A)

AZD8630 (reference formulation) via Monodose inhaler DRUG

Participants will receive AZD8630 via Monodose inhaler.

Sequence 1 (Treatment A- Treatment B); Sequence 2 (Treatment B- Treatment A)

Test inhaler DEVICE

Participants will receive AZD8630 via test inhaler.

Sequence 1 (Treatment A- Treatment B); Sequence 2 (Treatment B- Treatment A)

Monodose inhaler DEVICE

Participants will receive AZD8630 via Monodose inhaler.

Sequence 1 (Treatment A- Treatment B); Sequence 2 (Treatment B- Treatment A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy participants aged 18-55 years with suitable veins for cannulation or repeated venipuncture.
• Females participants of childbearing potential must not be lactating and, if sexually active, agree to use highly effective contraception from time of first administration of study intervention until 20 days after last dose of study intervention.
• All females must have a negative serum pregnancy test and must at the Screening Visit.
• Sexually active male participants and their partners of childbearing potential must be willing to use highly effective contraception measures from the time of first administration of study intervention administration until 20 days after the last dose of study intervention and on admission
• Healthy participants must have a FEV1 ≥ 80% of the predicted value regarding age, height, gender, and ethnicity at the Screening Visit.
• Have a BMI between 18 and 32 kg/m2 inclusive and weigh at least 45 kg.

You may not qualify if:

• History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant'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 important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
• History of any upper or lower respiratory tract infection in the 14 days before screening or during the Screening Period.
• Clinically significant history of atopy or allergy to common allergens including house dust mite and pollens, or a history of childhood asthma, as judged by the investigator.
• Medical history of or treatment for hepatitis B or hepatitis C.
• Other latent or chronic infections (e.g., recurrent sinusitis, genital or ocular herpes, or urinary tract infections) or at risk of infection (major surgery, major trauma, or significant infection) within 90 days of screening, or history of skin abscesses withing 90 days of screening.
• History of cancer within the last 10 years (20 years for breast cancer) except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed.
• Have received live, live attenuated or messenger ribonucleic acid vaccine in the 4 weeks prior to Screening Visit.
• History of or ongoing acquired or inherited immunodeficiency disorders including but not limited to HIV, common variable immunodeficiency or taking immune replacement therapy.
• A helminth parasitic infection diagnosed within 24 weeks of Visit 1 that has not been treated or has not responded to standard of care therapy.
• Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit.
• Any clinically important abnormalities in clinical chemistry or hematology results at screening and/or admission to the Clinical Unit, as judged by the investigator.
• Abnormal vital signs, after 5 minutes supine rest, at screening and/or admission to the Clinical Unit.
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at screening and/or admission to the Clinical Unit, as judged by the investigator that may interfere with the interpretation of QTc interval changes, a prolonged PR interval and abnormal ST wave morphology.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Model Details: This is an open-label, 2-period cross over study.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 6, 2024
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)