A Phase 0 Open Label Positron Emission Tomography Study to Assess the Biodistribution and Binding Characteristics of [11C]AZ14132516 Following Administration to Healthy Participants
- Trial ID
- 2022-502843-36-00
- Protocol
- D9690C00003
- Sponsor
- AstraZeneca AB
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the biodistribution of the radiotracer **[11C]AZ14132516** in the body following its administration to healthy participants. This is assessed using positron emission tomography (PET) imaging. Understanding the biodistribution is clinically relevant as it provides insights into the potential utility of the radiotracer in diagnosing or monitoring conditions such as **Crohn's disease**. The study does not specify any secondary objectives.
Participants
The clinical trial involves participants diagnosed with **Crohn's disease**. The study population includes both male and female subjects, with an age range of 18 to 65 years. The trial population was selected to include a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants' general health status, lifestyle considerations such as diet, physical activity, or habits, and key inclusion or exclusion criteria are not specified in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the distribution of the radiotracer **[11C]AZ14132516** in the body following administration to healthy participants. This study is a **Phase 1** trial, which is typically conducted to assess the safety, tolerability, and pharmacokinetics of a new compound. The trial employs a **randomized, double-blind, controlled** design to ensure the reliability and validity of the results. The estimated duration of the trial spans from June 1, 2023, to October 27, 2023, encompassing both the recruitment and study phases.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This visit will involve a comprehensive assessment, including medical history review and necessary diagnostic tests. Following successful screening, participants will be enrolled in the study and will attend scheduled follow-up visits. These visits are structured to monitor the participants' health status, collect data on the radiotracer's distribution, and ensure adherence to the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather endpoint data and evaluate any long-term effects.
The expected length of participant involvement is contingent upon the study schedule, with the possibility of early termination if specific conditions arise. These conditions may include adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants throughout the study duration.
Treatment
The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.
In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.
Efficacy
The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an initial investigation into the safety and potential efficacy of the intervention. The trial is scheduled to commence recruitment on June 1, 2023, with an estimated completion date of October 27, 2023. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 1 trials typically focus on safety and dosage, with preliminary efficacy assessments often included. The trial will likely employ standard methodologies for data collection and analysis, consistent with Phase 1 objectives, to ensure the reliability and validity of the findings. The absence of detailed endpoints suggests that the trial may utilize exploratory measures to guide future research phases.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.
- Participants ≥ 20 to 65 years of age inclusive, at the time of signing the ICF.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory parameters and ECG performed before first administration of investigational product.
- Body weight within 50.0 to 100.0 kg and body mass index within the range 18.0 to 30.0 kg/m2 (inclusive).
- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) Female participants: WOCBP must have a negative pregnancy test at screening and before PET examination (all premenopausal women, or in case when menstrual status cannot be ascertained in women under the age of 55 years). If sexually active with a non-sterilised male partner, must use at least one highly effective method of birth control during the study period and for 7 days following last radioligand administration. It is strongly recommended that non-sterilised male partners of female participants of childbearing potential use a male condom plus spermicide during the study period. Female participants must not breastfeed and must not donate or retrieve ova for their own use during the study period and for 7 days following last radioligand administration. b) Male participants: Non-sterilised male participants who are sexually active with a female partner of childbearing potential must use a condom with spermicide during the study period and for 7 days following last radioligand administration. It is strongly recommended that female partners of male participants also use at least one highly effective method of contraception throughout this period. In addition, male participants must refrain from fathering a child or donating sperm during the study period and for 7 days following last radioligand administration.
Exclusion Criteria
- Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal disease, or other major diseases.
- Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture (orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg).
- Significant abnormalities on the clinical examination, including neurological and physical examination, vital signs, ECG and clinical.
- Chemistry, hematology, or urine analysis results that may interfere with the study or present a safety risk to the patient.
- Abnormal vital signs, after 10 minutes of supine rest as judged by the PET centre physician. As a guide, any readings outside the following should be considered in the evaluation: a) systolic blood pressure (BP) ≥ 140 mmHg b) diastolic BP ≥ 90 mmHg c) heart rate ≤ 35 bpm or ≥ 100 bpm The inclusion of participants meeting the above criteria may be decided on a case-by case basis by PET centre physician.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This may include participants with any of the following: (a) PR (PQ) interval prolongation of clinical significance as judged by the Investigator (b) Intermittent second or third degree AV block (AV block II Mobitz type 1, Wenchebach, while asleep or in deep rest is not disqualifying) (c) Incomplete, full, or intermittent bundle branch block (QRS ≤ 110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy) (d) Abnormal T wave morphology, particularly in the protocol-defined primary lead (e) Prolonged QTcF ≥ 470 ms or shortened QTcF 340 ms or a family history of long QT syndrome. The inclusion of participants meeting the above criteria may be decided on a case-by case basis by PET centre physician.
- Known or suspected systemic infection (eg, hepatitis B virus, hepatitis C virus, HIV and tuberculosis), including previous or ongoing infectious or autoimmune disease.
- Participants must abstain from taking prescription or non-prescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Current drug abuse or dependence or positive screen for drugs of abuse at screening visit.
- Participants on anticoagulant treatment.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
- Participant has abnormal blood flow confirmed by a negative Allen’s test in both hands at screening.
- Blood donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
- Positive SARS-CoV-2 rapid antigen test at screening
- Any other reason that, in the study PI opinion, prohibits the inclusion of the participants into the study.
- Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Sweden | Not Recruiting | 01 Jun 2023 | 9 |