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AzTrials

Healthy ParticipantsPhase 1NCT06531811

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

A Phase 1 study testing AZD8630 (test formulation) via test inhaler, AZD8630 (reference formulation) via Monodose inhaler and Test inhaler in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
AZD8630 (test formulation) via test inhaler, AZD8630 (reference formulation) via Monodose inhaler and Test inhaler
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
6 Aug 2024to 3 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Current smokers or those who have smoked or used nicotine products or inhalational cannabis/marijuana products (including e-cigarettes) within the previous 6 months prior to screening or has smoking history of > 10 pack years. Known or suspected history of alcohol.
  • Known or suspected history of alcohol or drug abuse (including cannabis/marijuana products) or excessive intake of alcohol as judged by the investigator. The use of oral cannabis is permitted.
  • Positive screen for drugs of abuse (including any cannabis/marijuana products), or alcohol or cotinine (nicotine) at screening or on admission to the Clinical Unit.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator.
  • History of hypersensitivity or anaphylaxis to any components of AZD8630 formulation.
  • History of documented immune complex disease (Type III hypersensitivity reactions) to mAb administration.
  • Receipt of immunoglobulin or blood products within 4 weeks prior to Screening Visit.
  • Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (eg, > 5 cups of coffee [one cup ~100 mg caffeine]; one cup of tea ~30 mg caffeine) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
  • Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of study intervention.
  • Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
  • Participants who have previously received AZD8630.
  • Participants who have medical dietary restrictions or dietary restrictions for which the site are unable to cater.
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days of the first administration of study intervention in this study or within 5 half-lives of the medication, whichever is the longest.
  • Pregnancy or intention to become pregnant during the study, breastfeeding, or unwillingness to use a highly effective method of contraception throughout the study in female participants of childbearing potential or lactating woman.
  • Judgment by the investigator that the participant should not participate in the study if they have any ongoing or recent (i.e., during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
  • Vulnerable participants, e.g., kept in detention, protected adults under guardianship

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Randomized, Open-label, Single-dose, 2-Treatment, 2-Period, Crossover Study to Assess the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants.

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.

Read the detailed description

This is a randomized, open-label, 2- treatment, 2- period study with a duration of approximately 6 weeks.

The Study will comprise of:

  • A Screening period of 28 days,
  • Treatment Period 1 on Day 1 and Treatment Period 2 on Day 9
  • A Follow-up visit within 7 days (± 2 days) after the last dose in Period 2.

Participants will be randomized 1:1 to either Sequence 1 or Sequence 2.

  • Sequence 1: Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder).
  • Sequence 2: Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder).
Being tested
AZD8630 (test formulation) via test inhaler, AZD8630 (reference formulation) via Monodose inhaler, Test inhaler, Monodose inhaler
Keywords
Trehalose/leucine/trileucine/citrate (TLTC), Trehalose/leucine/trileucine/histidine (TLTH), Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD8630 (test formulation) via test inhalerDrug

    Participants will receive AZD8630 via test inhaler.

  • AZD8630 (reference formulation) via Monodose inhalerDrug

    Participants will receive AZD8630 via Monodose inhaler.

  • Test inhalerDevice

    Participants will receive AZD8630 via test inhaler.

  • Monodose inhalerDevice

    Participants will receive AZD8630 via Monodose inhaler.

Study groups in NCT06531811
Study groupRoleWhat they receive
Sequence 1 (Treatment A- Treatment B)ExperimentalParticipants will receive Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder)
Receives: 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)ExperimentalParticipants will receive Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder)
Receives: Drug: AZD8630 (test formulation) via test inhaler; Drug: AZD8630 (reference formulation) via Monodose inhaler; Device: Test inhaler; Device: Monodose inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Baseline Day 1 to Day 11

Secondary outcomes (16)

  1. Maximum observed plama (peak) drug concentration (Cmax)

    To evaluate the Cmax of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

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

    To evaluate the AUCinf of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

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

    To evaluate the AUClast of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

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

    To evaluate the tmax of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

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

    To evaluate the tlast of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  6. Typical elimination rate constant (λz)

    To evaluate the λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  7. Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)

    To evaluate the t½λz of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  8. Area under the plasma concentration curve from zero to 24 (AUC [0-24])

    To evaluate the AUC (0-24) of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  9. Area under the plasma concentrationcurve from zero to 24, divided by dose (AUC [0-24]/D)

    To evaluate the (AUC [0-24]/D) of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  10. Area under the plasma concentration curve from zero to infinity, divided by dose (AUCinf/D)

    To evaluate the AUCinf/D of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  11. Extrapolated area under the curve from tlast to infinity, expressed as percentage of AUCinf (%AUCextr)

    To evaluate the %AUCextr of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  12. Maximum observed plama (peak) drugconcentration, by dose (Cmax/D)

    To evaluate the Cmax/D of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  13. Apparent total body clearence of drugfrom plasma after extravascularadministration (CL/F)

    To evaluate the CL/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  14. Volume of distribution (apparent) at steady state following extravascularadministration based on terminalphase (Vz/F)

    To evaluate the Vz/F of AZD8630 following inhaled administration of the AZD8630 test formulation and the AZD8630 Monodose formulation.

    Measured: From Baseline Day 1 to Day 11

  15. Number of participants with adverse event (AEs)

    To further assess the safety and tolerability following single inhaled administration of AZD8630 test formulation and AZD8630 Monodose formulation in healthy participants.

    Measured: From Screening (Day -28) to Follow-up visit (7 days post last dose of AZD8630)

  16. Number of AEs and SAEs associated with test device

    To assess the safety and performance of the test device.

    Measured: From Baseline Day 1 to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start6 Aug 2024
  3. Primary completion3 Oct 2024
  4. Study completion3 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
This is an open-label, 2-period cross over study.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06531811
Sponsor's protocol ID
D6830C00002
Status last verified
Oct 2024
First submitted
29 Jul 2024
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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 approved.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD8630 (test formulation) via test inhaler, AZD8630 (reference formulation) via Monodose inhaler and Test inhaler in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the serum concentration-time curve from time zero to the last quantifiable concentration test/Monodose (time frame: From Baseline Day 1 to Day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06531811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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