[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"food-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:food-effect":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100618641","phase-1-a-study-to-evaluate-the-food-effect-on-rnk08954-in-healthy-participants-and-the-mass-balance-study-of-14crnk08954-in-healthy-adult-male-subjects-100618641",false,"NCT07334262","A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects","A Study to Evaluate the Food Effect on the Pharmacokinetics of RNK08954 Tablets and to Assess the Mass Balance of [14C]RNK08954 in Healthy Adult Male Subjects in China","Inclusion Criteria:\n\n* Healthy, adult, male or female, 18-45 years of age, inclusive, at the screening visit.\n* Male participants must have a body weight of no less than 50 kg, and female participants must have a body weight of no less than 45 kg. The Body mass index (BMI) should be between 19 and 26 kg\u002Fm² (inclusive).\n* Must follow protocol specified contraception guidance.\n* Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n* Clinically significant abnormalities found in comprehensive physical examinations, vital signs, laboratory tests, 12-lead electrocardiogram, chest X-ray, etc.\n* Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody.\n* Individuals with allergic constitution.\n* Any history of clinically significant diseases or conditions that, in the investigator's judgment, may affect the trial results.\n* History or family history of organic heart disease, heart failure, myocardial infarction, angina pectoris, torsades de pointes, ventricular tachycardia, QT prolongation syndrome.\n* Gastrointestinal diseases that cause clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of vomiting or diarrhea within one week prior to screening.\n* Individuals with dysphagia.\n* Undergone major surgery within six months prior to the first dose or whose surgical incision has not fully healed.\n* Used investigational drugs or received other experimental treatments within three months prior to the first dose or are currently participating in any other interventional clinical trials.\n* Vaccinated within one month prior to the first dose or plan to be vaccinated during the trial period.\n* Used any drugs affecting drug-metabolizing enzymes or transporters within 30 days prior to the first dose.\n* Taken any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 14 days prior to the first dose.\n* Smoke more than 10 cigarettes per day or habitually use nicotine-containing products within three months prior to the first dose.\n* Current or previous alcohol abuse, or frequent alcohol consumption within six months prior to the first dose, or those with a positive alcohol breath test.\n* History of drug abuse, use of soft drugs within three months prior to the first dose, or use of hard drugs within one year prior to the first dose, or those with a positive urine drug abuse screening.\n* Individuals who habitually or excessively consume grapefruit juice, tea, coffee, and\u002For caffeinated beverages.\n* History of blood loss or blood donation (≥400 mL) within three months prior to the first dose, those who have received blood transfusions or blood products within one month prior to the first dose, or those who plan to donate blood within three months after the trial.\n* Special dietary requirements, intolerance to high-fat meals, or inability to comply with a standardized diet.\n* History of needle or blood phobia, difficulty with blood collection, or intolerance to venipuncture.\n* Pregnant or lactating women.\n* have poor compliance or other factors that make them unsuitable for participation in this trial.",true,"ALL","18 Years","45 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","An Study of Orally Administered RNK08954 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of RNK08954，Mass Balance Study of \\[14C\\] RNK08954 in Chinese Healthy Adult Male Subjects",[28,29],"Food Effect","Mass Balance","NOT_YET_RECRUITING","2026-01-12",{"date":33,"type":34},"2026-01-14","ACTUAL",{"date":36,"type":22},"2025-12-31",{"date":38,"type":22},"2026-12-01",{"name":40,"class":41},"Ranok Therapeutics (Hangzhou) Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100600528","phase-2-food-effect-efficacy-and-safety-of-mkp10241-in-healthy-and-obese-adult-participants-with-and-without-diabetes-100600528","NCT07098663","Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes","A Phase 2a, Double-blind, Randomized, Placebo-controlled, Study to Assess Food Effect, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of MKP10241 in Healthy and Obese Adult Participants, With and Without Type 2 Diabetes Mellitus","Inclusion criteria\n\n* Male or female participants between 18 to 60 years of age\n* Considered healthy by the Investigator. Part 1: BMI of 18 to 30 kg\u002Fm2, and weight being not less than 50 kg. Part 2\u002F3: BMI of ≥32 kg\u002Fm2\n* Part 1\u002F2: Fasting plasma glucose (FPG) between 3.9 mmol\u002FL and 6.1 mmol\u002FL. Part 3: FPG greater than or equal to 6.94 mmol\u002FL and less than or equal to 14.43 mmol\u002FL\n* A nonsmoker\u002Fsocial smoker, defined as not having smoked more than 5 cigarettes or equivalent per day in the 3 months prior to Screening.\n* Able to abstain from the consumption of alcohol and any alcohol-containing products from 48 hours before dosing to the End of Study Visit.\n* 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\n* 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.\n* Capable of giving signed Informed Consent\n* Willing and able to adhere to study restrictions and to be confined at the CRU.\n* Part 3: Participants with an established diagnosis of type 2 diabetes mellitus\n* 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\n\nExclusion criteria\n\n* Clinically significant haematological findings at Screening.\n* 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\u002FL, serum amylase or lipase ≥1.5 times ULN at Screening.\n* Renal impairment, such as creatinine ≥ULN, estimated glomerular filtration rate (eGFR) of ≤80 mL\u002Fminute\u002F1.73m2 in adults, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\n* Positive polymerase chain reaction (PCR) test for severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2)\n* A history of non-febrile seizures.\n* Positive pregnancy test result at Screening or on admission to the CRU,\n* Any major surgery within 60 days prior to Screening, or planned major surgery during the study.\n* Any history of malignant disease excluding surgically resected skin and in-situ cervical squamous cell or basal cell carcinoma.\n* Suspected hypersensitivity to MKP10241 and any components of MKP10241 liquid suspension\n* Any other condition which makes the participant unsuitable for study participation as judged by the Investigator or designee.\n* Participant has any history or evidence of any clinically significant disease\n* Prior or planned (during study period) bariatric surgery (e.g. gastric bands, gastroplasty Roux-e-Y gastric bypass) or ileal resection.\n* Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-V) substance use disorders and alcohol abuse within 12 months prior to Screening and\u002For positive alcohol breath test at Screening or admission.\n* Positive result for drugs of abuse at Screening or admission.\n* Use of live attenuated vaccines within 14 days prior to dosing\n* The use of medications (other than paracetamol), including hormonal contraceptives\n* Receipt of any other investigational medicinal product within one month or five half-lives (whichever is longer) prior to dosing.\n* Clinically significant ECG findings: QTcF value ≥450 ms for males or ≥470 ms for females at Screening or Day -1\n* Participants with a mean systolic blood pressure \\>140 mmHg, mean diastolic blood pressure \\>90 mmHg at Screening.\n* Positive blood screen for human immunodeficiency virus antibody (HIV), hepatitis B surface antigen (HBsAg), syphilis, hepatitis C virus (HCV).\n* Change in body weight of ≥ 10% within 3 months prior to the Screening visit.\n* 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.\n* Part 3: Type 1 diabetes mellitus, maturity-onset diabetes of the young, or other forms of diabetes.","60 Years",{"count":52,"type":22},68,[54],"PHASE2","The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts. The main parameters it aims to answers are :\n\n1. Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants?\n2. Will multiple ascending doses of MKP10241 in obese participants with or without T2DM characterize changes in the plasma pharmacokinetic profile and pharmacodynamic effects?\n3. What treatment emergent adverse events or discontinuation is experienced following single and multiple ascending doses of MKP10241 in healthy and obese participants with or without T2DM?\n\nThis study will be compared against a placebo which is matched in appearance to MKP10241 at dosage strengths.\n\nParticipants will:\n\n1. Part 1: Take MKP10241 400 mg or Placebo on Day 1 and Day 8. Part 2: Take MKP10241 200 mg, 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 Part 3: Take MKP10241 300 mg and 400 mg or Placebo daily from Day 1 to Day 28\n2. Visit the clinical research unit for dose administration, admission or follow up.\n3. Will be monitored by the Safety Monitoring Committee.",[57,28,58,59],"Type 2 Diabetes Mellitus (T2DM)","Safety and Tolerability","Obesity",[61,62,63,64,65],"MKP10241","Safety and tolerability of MKP10241","Pharmacokinetics and Pharmacodynamics of MKP10241","Management of T2DM with MKP10241","Management of Obesity with MKP10241","RECRUITING","2025-09-24",{"date":69,"type":34},"2025-09-29",{"date":71,"type":34},"2025-08-12",{"date":73,"type":22},"2026-04-17",{"name":75,"class":41},"Mankind Pharma Limited"]