Parkinson's Disease
Conditions
Interventions
Treatment period 1: 30 mg YTX-7739 tablet formulation (2 tablets of 15mg).
Treatment period 2: 30 mg YTX-7739 capsule formulation (2 capsules, 1x25mg, 1x5
mg)
Treatment period 3: 30 mg YTX-7739 tab
Sponsors
Yumanity Therapeutics
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult male or female subjects 18-55 years of age, inclusive; defined as absence of evidence of any active acute or chronic disease or illness following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry and urinalysis; 2. Body mass index (BMI) between 18-30 kg/m2, inclusive, and with a minimum weight of 50kg and maximum weight of 100kg.
Exclusion criteria
Exclusion criteria: 1. Clinically significant findings as determined by medical history taking, physical examination, ECG, laboratory findings (including lipid or hormone profiles) and vital signs, as judged by the investigator. 3. Subjects with a QTcF of > 450 ms for males and > 470 ms for females at screening or a history of long QT syndrome. 8. Being on a diet composed of relevantly altered amounts of fat, protein or carbohydrates that may affect triglyceride and fatty acid levels (such as high-fat, gluten-free, carbohydrate-free, protein rich diets). 10. Gastrointestinal disease (such as irritable bowel syndrome, inflammatory bowel disease, chronic gastritis, peptic ulcer disease, etc.) that could affect absorption of the study drug. 11 History of gastric surgery, including Roux-en-Y gastric bypass surgery, an antrectomy with vagotomy, or gastrectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Relative bioavailability of Cmax and AUC0-120h of 30 mg tablet vs capsule * PK parameters of YTX-7739 as tablet formulation by non-compartmental analysis of the plasma concentration-time data: o AUC0-120h, AUClast, AUC extrapolated, CL/F, Cmax, T1/2, Tlag, Tmax, Vz/F * Change in PK parameters of YTX-7739 as tablet formulation after administration after a high-fat breakfast by non-compartmental analysis of the plasma concentration-time data: o AUC120h, AUClas, AUC extrapolated, CL/F, Cmax, T1/2, Tlag, Tmax, Vz/F | — |
Secondary
| Measure | Time frame |
|---|---|
| * Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit * Concomitant medication throughout the study at every study visit * Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule * Clinical laboratory tests (Hematology, blood chemistry and urinalysis) as per assessment schedule * ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per assessment schedule * AUC0-inf as tablet and capsule formulation, and change in AUC0-inf after a high-fat breakfast, by non-compartmental analysis on the plasma concentration-time data. | — |
Countries
Netherlands
Outcome results
None listed