Trials Sponsors Conditions Drugs Pricing

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
+11 more secondary outcomes

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 inhalerDrug: AZD8630 (reference formulation) via Monodose inhalerDevice: Test inhalerDevice: 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 inhalerDrug: AZD8630 (reference formulation) via Monodose inhaler

Interventions

AZD8630 (test formulation) via test inhalerDrug

Participants will receive AZD8630 via test inhaler.

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

AZD8630 (reference formulation) via Monodose inhalerDrug

Participants will receive AZD8630 via Monodose inhaler.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (1)

Research Site

Baltimore, Maryland, 21225, United States

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

August 6, 2024

Actual (reported)

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.
+16 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (2)

Sequence 1 (Treatment A- Treatment B)

Sequence 2 (Treatment B- Treatment A)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (2)

Sequence 1 (Treatment A- Treatment B)

Sequence 2 (Treatment B- Treatment A)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations