Healthy Participants, Obesity
Conditions
Keywords
First time in human, Single ascending dose, Multiple ascending dose, Pharmacokinetics, Pharmacodynamics
Brief summary
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.
Detailed description
This is a phase 1, first time in human (FTiH) randomized, single-blind, placebo-controlled study in healthy male and female participants living with overweight and/or obesity, with female participants being of non-childbearing potential. It consists of 2 parts: Part A (single ascending doses: SAD): This will consist of Part A1 (Global SAD (GSAD)) with 6 cohorts, Part A2 (Japanese SAD (JSAD)) with 2 cohorts and Part A3 (Chinese SAD (CSAD)) with 1 cohort. Part B (multiple ascending doses: MAD): This will consist of Part B1 (Global MAD (GMAD)) with 3 cohorts and Part B2 (Japanese MAD (JMAD)) with 1 cohort. Participants are only allowed to participate in one of the cohorts. Both Part A and Part B will comprise of: * Screening period (up to 5 weeks). * Treatment period. * Safety follow-up period.
Interventions
DRUGAZD1043
Single or multiple doses of AZD1043 will be administered.
OTHERPlacebo
Matching placebo to AZD1043 will be administered.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit. * Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. * Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts \[Parts A1 and B1\]), or 23 and 39.9 kg/m2 (Japanese \[Parts A2 and B2\] and Chinese \[Part A3\] cohorts) inclusive and weigh at least 50 kg. * For the Parts A2 and B2, participants should be Japanese (natives of Japan or Japanese Americans), having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan. * For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
Exclusion criteria
* History of any clinically important disease or disorder. * 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. * Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs. * History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043. * Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit. * History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs) | Part A (SAD): From Day-35 to Day 253; Part B (MAD): From Day 1 to Day 253 | To assess the safety and tolerability of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under concentration-time curve from time 0 to infinity (AUCinf) (Part A only) | From Day 1 to Day 253 | To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent. |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | From Day 1 to Day 253 | To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent. |
| Maximum observed drug concentration (Cmax) | From Day 1 to Day 253 | To characterize the PK of a single or multiple doses of AZD1043 in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent. |
Countries
United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed