Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes

Korábbi kezelés

• Any major surgery within 60 days prior to Screening, or planned major surgery during the study.
• Prior or planned (during study period) bariatric surgery (e.g. gastric bands, gastroplasty Roux-e-Y gastric bypass) or ileal resection.
• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) substance use disorders and alcohol abuse within 12 months prior to Screening and/or positive alcohol breath test at Screening or admission.
• Positive result for drugs of abuse at Screening or admission.
• Use of live attenuated vaccines within 14 days prior to dosing
• The use of medications (other than paracetamol), including hormonal contraceptives
• Receipt of any other investigational medicinal product within one month or five half-lives (whichever is longer) prior to dosing.
• Change in body weight of ≥ 10% within 3 months prior to the Screening visit.
• Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products, plasma) or acute loss of blood during the 30 days prior to Screening.

Más betegség

• Positive polymerase chain reaction (PCR) test for severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2)
• A history of non-febrile seizures.
• Any history of malignant disease excluding surgically resected skin and in-situ cervical squamous cell or basal cell carcinoma.
• Suspected hypersensitivity to MKP10241 and any components of MKP10241 liquid suspension
• Any other condition which makes the participant unsuitable for study participation as judged by the Investigator or designee.
• Participant has any history or evidence of any clinically significant disease
• Positive blood screen for human immunodeficiency virus antibody (HIV), hepatitis B surface antigen (HBsAg), syphilis, hepatitis C virus (HCV).
• Part 3: Type 1 diabetes mellitus, maturity-onset diabetes of the young, or other forms of diabetes.

Laborértékek

• Hepatic impairment including aspartate aminotransferase (AST), alanine transaminase (ALT), or alkaline phosphatase ≥1.5 times upper limit of normal (ULN), total bilirubin ≥2.0 times ULN, albumin ≤3.0 g/L, serum amylase or lipase ≥1.5 times ULN at Screening.
• Renal impairment, such as creatinine ≥ULN, estimated glomerular filtration rate (eGFR) of ≤80 mL/minute/1.73m2 in adults, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

Egyéb

• Clinically significant haematological findings at Screening.
• Positive pregnancy test result at Screening or on admission to the CRU,
• Clinically significant ECG findings: QTcF value ≥450 ms for males or ≥470 ms for females at Screening or Day -1
• Participants with a mean systolic blood pressure >140 mmHg, mean diastolic blood pressure >90 mmHg at Screening.

• Male or female participants between 18 to 60 years of age
• Considered healthy by the Investigator. Part 1: BMI of 18 to 30 kg/m2, and weight being not less than 50 kg. Part 2/3: BMI of ≥32 kg/m2
• Part 1/2: Fasting plasma glucose (FPG) between 3.9 mmol/L and 6.1 mmol/L. Part 3: FPG greater than or equal to 6.94 mmol/L and less than or equal to 14.43 mmol/L
• A nonsmoker/social smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the 3 months prior to Screening.
• Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing to the End of Study Visit.
• Female participants must be of nonchildbearing potential or, if of childbearing potential, must agree to use 1 form of highly effective contraceptive method, plus an additional barrier method of contraception between signing consent
• Male participants who are sexually active must use a condom from Screening until at least 90 days after the last dose of study intervention (or be surgically sterile. Female partners of childbearing potential must use a highly effective method of contraception.
• Capable of giving signed Informed Consent
• Willing and able to adhere to study restrictions and to be confined at the CRU.
• Part 3: Participants with an established diagnosis of type 2 diabetes mellitus
• Part 3: Participants; type 2 diabetes mellitus must be managed by diet and exercise alone or by stable dose of metformin (for ≥2 months); the use of other antidiabetic therapies is prohibited