Evaluation of AZD8154 Concentrations in Blood

  • STATUS
    Recruiting
  • participants needed
    15
  • sponsor
    AstraZeneca
Send
Updated on 19 February 2024
See if I qualify
hysterectomy
oophorectomy
follicle stimulating hormone
forced expiratory volume
bilateral salpingectomy
hormone level

Summary

This study is intended to evaluate the systemic pharmacokinetic (PK) characteristics and the safety of AZD8154 following administration of the Monodose DPI formulation compared with the administration of the nebuliser suspension.

Description

This study will be a randomised, open-label, 3-period, single-dose, single-centre, crossover study in healthy males and healthy females of non-childbearing potential.

The study will comprise:

  • A Screening Period of maximum 28 days;
  • Three treatment periods during which subjects will be resident at the Clinical Unit from the morning of the day before dosing with AZD8154 or placebo (Day 1) until 72 hours following dosing for collection of PK samples; discharged on the morning of Day 4 of each treatment period;
  • A Follow up Visit within 6 1 days after last dose administration of investigational medicinal products (IMPs) (i.e., AZD8154 or placebo).

A total of 15 healthy subjects will be randomised in this study to ensure that at least 12 subjects are evaluable.

Each subject will be involved in the study for approximately 9 weeks.

Details
Condition Asthma, Asthma, Asthma (Pediatric), Allergies & Asthma, Asthma (Pediatric), Allergies & Asthma
Age 18years - 55years
Treatment AZD8154 nebuliser, AZD8154 Monodose DPI presented in capsules, AZD8154 Placebo Monodose DPI presented in capsules
Clinical Study IdentifierNCT04480879
SponsorAstraZeneca
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male and/or healthy female subjects of non childbearing potential aged 18 to 55 years (inclusive at the Screening Visit) with suitable veins for cannulation or repeated venipuncture
Females must have a negative pregnancy test at Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at Screening by fulfilling 1 of the following criteria (i) Females are considered postmenopausal if they have had amenorrhea for at least 12 months without an alternative medical cause. The following age specific requirements apply: Women under 50 years old are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments and with luteinising hormone and follicle stimulating hormone levels are in the postmenopausal range
Women over 50 years of age would be considered postmenopausal if they have
been amenorrheic for 12 months or more following cessation of all exogenous
hormonal treatments
(ii) Documentation of irreversible surgical sterilization by hysterectomy
bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
\. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh
at least 60 kg and no more than 100 kg inclusive
\. Subject has a forced expiratory volume in 1 second 80% of the predicted
value regarding age, height, gender and ethnicity at the Screening Visit

Exclusion Criteria

History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
Subject is immune compromised
History of diabetes, impaired fasting glucose, metabolic syndrome, hypertriglyceridemia or familial lipid disorders
Current or previous history of malignancy of any kind except cutaneous basal or squamous cell carcinoma successful treated with therapy
History of any respiratory disorders such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis (IPF), or infantile bronchiolitis
Subject with latent or active tuberculosis, as confirmed by a positive QuantiFERON TB Gold test or as judged by the Investigator at the Screening Visit
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs, or bowel disorders not otherwise specified
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IMP
Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results, defined as the following
(i) Alanine aminotransferase and/or aspartate aminotransferase > 1.5 x the
upper limit of the normal (ULN) laboratory range
(ii) Bilirubin > 1.5 times the ULN laboratory range. (iii) Absolute neutrophil
count < lower limit of normal (LLN). (iv) Absolute lymphocyte count < LLN
\. Any positive result at the Screening Visit for serum hepatitis B surface
antigen OR hepatitis B core antibodies, hepatitis C virus antibody (anti HCV)
and human immunodeficiency virus
\. Abnormal vital signs, after 5 minutes supine rest, defined as any of the
following
(i) Systolic blood pressure (BP) < 90 mmHg or > 140 mmHg. (ii) Diastolic BP <
mmHg or > 90 mmHg. (iii) Pulse < 50 or > 90 beats per minute (bpm)
\. Any clinically important abnormalities in rhythm, conduction or
morphology of the 12 lead safety ECG as judged by the Investigator
(i) Prolonged QT interval corrected for heart rate using Fridericia's formula
(QTcF) > 450 ms or shortened QTcF < 340 ms or family history of long QT
syndrome
(ii) PR (PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is
acceptable if there is no evidence of ventricular pre excitation)
(iii) PR (PQ) interval prolongation (> 220 ms) intermittent second (Wenckebach
block while asleep is not exclusive) or third degree atrioventricular (AV)
block, or AV dissociation
(iv) Persistent or intermittent complete bundle branch block (BBB), incomplete
bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with
QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there
is no evidence of e.g., ventricular hypertrophy or pre excitation
\. Previous use of a mechanistic target of rapamycin (mTOR) antagonist
(e.g., rapamycin, everolimus) or PI3K inhibitor (selective or non selective
PI3K inhibitors)
\. Known or suspected history of drug abuse as judged by the Investigator
\. Current smokers or those who have smoked or used nicotine products
(including e cigarettes) within the previous 3 months
\. History of alcohol abuse or excessive intake of alcohol as judged by the
Investigator
\. Positive screen for drugs of abuse or cotinine (nicotine) at the
Screening Visit or admission to the Clinical Unit or positive screen for
alcohol on admission to the Clinical Unit before the first administration of
the IMP
\. History of severe allergy/hypersensitivity or ongoing clinically
important allergy/hypersensitivity, as judged by the Investigator or history
of hypersensitivity to drugs with a similar chemical structure or class to
AZD8154
\. Receipt of live attenuated vaccines 2 months before first administration
of the IMP and 3 months after the last IMP administration
\. Excessive intake of caffeine-containing drinks or food (e.g., coffee
tea, chocolate) as judged by the Investigator
\. Use of drugs with cytochrome P450 (CYP) 3A enzyme inducing or inhibition
properties within 3 weeks before first administration of IMP
\. Use of any prescribed or nonprescribed medication including antacids
analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose
vitamins (intake of 20 to 600 times the recommended daily dose) and minerals
during the 2 weeks before the first administration of the IMP or longer if the
medication has a long half life
\. Plasma donation within 1 month of the Screening Visit or any blood
donation/blood loss > 500 mL during the 2 months before the Screening Visit
\. Has received another new chemical entity (defined as a compound which has
not been approved for marketing) within 3 months of the first administration
the IMP in this study. The period of exclusion begins 3 months after the final
dose or 1 month after the last visit whichever is the longest
\. Involvement of any Astra Zeneca or study site employee or their close
relatives
\. Judgement by the Investigator that the subject 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
\. Subjects who cannot communicate reliably with the Investigator and/or is
not able to read speak and understand the German language
\. Vulnerable subjects, e.g., kept in detention, protected adults under
guardianship, trusteeship or committed to an institution by governmental or
juridical order
\. Subject has a positive test result for SARS-CoV-2 RT-PCR before
randomisation
\. Subject has clinical signs and symptoms consistent with COVID-19, e.g
fever, dry cough, dyspnoea, sore throat, fatigue, or confirmed infection by
appropriate laboratory test within the last 4 weeks prior to screening or on
first admission
\. History of severe COVID-19 (hospitalisation, extracorporeal membrane
oxygenation, mechanically ventilated)
\. Subjects who are regularly exposed to COVID-19 as part of their daily
life (e.g., health care professionals working in COVID-19 wards or at
emergency departments)
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

hysterectomy
oophorectomy
follicle stimulating hormone
forced expiratory volume
bilateral salpingectomy
hormone level

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.