Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese

• Status: Not yet recruiting
• Trial end date: 2023-05-09
• Target enrollment: 0
• Participant gender: All

Summary

A study in healthy male and female participants of non-childbearing potential who are overweight or obese.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures.

• Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.

• Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:

(i) Post menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle stimulating hormone (FSH) levels in the post menopausal range.

(ii) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

• Have a body mass index (BMI) of 25 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.

For the Japanese cohort(s):

• Participant is a native of Japan; defined as having both parents and four grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.

• Have a BMI of 23 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.

Exclusion Criteria:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the participant's ability to participate in the study, including:

(i) gastroparesis (or similar) requiring treatment, or (ii) previous surgery of the upper gastrointestinal tract

• 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 IMP.

• Any laboratory values with the following deviations:

(i) Alanine aminotransferase > Upper limit of normal (ULN) (ii) Aspartate aminotransferase > ULN (iii) eGFR < 60 ml/min/1.73 m2 (calculated using the CKD EPI formula) (iv) White blood cell count < LLN (v) Hemoglobin < LLN (vi) Calcium < LLN

• Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

(i) Systolic Blood pressure (BP) < 90 mmHg or > 140 mmHg. (ii) Diastolic BP < 50 mmHg or > 90 mmHg. (iii) Heart rate < 45 or > 85 beats per minute (bpm)

• 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 AZD6234.

• Participants who are vegans or have medical dietary restrictions.

• Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.