A phase 1 pharmacokinetic study to assess and compare the relative bioavailability of a capsule and a tablet formulation of YTX-7739 following single oral doses administered with and without food in Healthy Volunteers

Completed

Conditions: Parkinson's Disease
10028037

Registration Number: NL-OMON50260

Lead Sponsor: Yumanity Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Relative bioavailability of Cmax and AUC0-120h of 30 mg tablet vs capsule<br /><br>* PK parameters of YTX-7739 as tablet formulation by non-compartmental analysis<br /><br>of the plasma concentration-time data:<br /><br>o AUC0-120h, AUClast, AUC extrapolated, CL/F, Cmax, T1/2, Tlag, Tmax, Vz/F<br /><br>* Change in PK parameters of YTX-7739 as tablet formulation after<br /><br>administration after a high-fat breakfast by non-compartmental analysis of the<br /><br>plasma concentration-time data:<br /><br>o AUC120h, AUClas, AUC extrapolated, CL/F, Cmax, T1/2, Tlag, Tmax, Vz/F</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at<br /><br>every study visit<br /><br>* Concomitant medication throughout the study at every study visit<br /><br>* Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic<br /><br>blood pressure (mmHg)) as per assessment schedule<br /><br>* Clinical laboratory tests (Hematology, blood chemistry and urinalysis) as per<br /><br>assessment schedule<br /><br>* ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per<br /><br>assessment schedule<br /><br>* AUC0-inf as tablet and capsule formulation, and change in AUC0-inf after a<br /><br>high-fat breakfast, by non-compartmental analysis on the plasma<br /><br>concentration-time data.</p><br>