None listed
Conditions
Interventions
Intervention1: PDP-117 Tablet: light yellow coloured caplet shaped tablet.
Route of administration: Oral.
Dose and frequency: Cohort 1, 2 & 3 will be dosed with single oral dose 01 tablet (600 mg) ,
Sponsors
Indian Council of Medical Research
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Able to understand and comply with study specific restrictions and prohibitions. Able to understand and give voluntary written informed consent for participation in the trial before initiation of any study procedure. Healthy, adult, human subjects aged 18 to 45 years (both inclusive) at the time of screening. Male subject who is non-sterilized and sexually active with a female partner, agree to use a suitable and effective double barrier contraceptive method (e.g. a condom and diaphragm) for entire duration of the study and until 120 days after the last dose of study drug. Female subjects of child bearing potential who agree to use a suitable and effective double barrier contraceptive method (e.g. a condom and diaphragm) for entire duration of the study and until 120 days after the last dose of study drug. Female subjects who are of child bearing potential and are surgically sterilized at least 6 months prior to study participation. Female subjects who are tested negative for urine pregnancy test at the time of screening and serum pregnancy test prior to check-in. Female subjects who has surgically sterilized partner (for at least 6 months). Female subjects who are post-menopausal for at least 2 years.
Exclusion criteria
Exclusion criteria: Subject who received any investigational product within 90 days prior to the first dose of study drug. Subject with an immediate family member as NCS employee, or is in a dependent relationship with a NCS employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress. Subject with history or presence of any markedly abnormal illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine or psychiatric, disease or disorder or other abnormality which may affect safety or can potentially reduce drug clearance (example, renal or hepatic insufficiency). Subject having any markedly abnormal laboratory value or electrocardiogram (ECG) at screening or check-in or having Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) >1.5 upper limit of normal (ULN) at screening or check-in. Subject with a known hypersensitivity to any component of the formulation of PDP-117. Subjects with hypersensitivity to chickpeas or peanut. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria. Ingestion of any medicine at any time within 4 weeks prior to check-in. Subject with positive result for COVID-19 test done before check-in. Subject with a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or a known history of human immunodeficiency virus (HIV) infection at screening. Subject with a positive history for drugs of abuse (defined as any illicit drug use) at screening or check-in, or a history of alcohol abuse within 1 month prior to screening or is unwilling to agree to abstain from alcohol and drugs throughout the study. Positive result from the urine drug screening and/or alcohol breath analysis done at screening and/or check-in. Subject who has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) for at least 48 hours prior to check-in. Subject who has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to first dose of study drug. Subject with blood pressure outside the ranges i.e. systolic BP (greater than 140 or �90 mmHg) and diastolic BP (�50 to > 90 mmHg) at the time of screening. If out of range, assessment may be repeated once for eligibility determination at the time of screening and/or check-in. Has a resting heart rate outside the range of 50 to 90 bpm (not on ECGs) at the time of screening. If out of range, the assessment may be repeated once for eligibility determination at the time of screening and/or check-in. Difficulty in swallowing capsules and/or tablets. Female subjects who are taking warfarin or aspirin. Female subjects demonstrating a positive pregnancy screen or currently breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of PDP-117 when administered as single and multiple oral doses at escalating dose levels in healthy subjects.Timepoint: SRD:-1.00,-0.50,0.00,0.25,0.50,0.75,1.00,1.50,2.00,3.00,4.00,6.00,8.00,10.00,12.00,16.00,20.00,24.00,36.00,48.00.Food effect:-1.00,-0.50,0.00,0.25,0.50,1.00,1.50,2.00,3.00,4.00,5.00,6.00,7.00,8.00,10.00,12.00,16.00,20.00,24.00,36.00,48.00.MRD:-1.00,-0.50,0.00,2.00,4.00,8.00,12.00,24.00,72.00,120.00,216.00,288.00,312.00,314.00,316.00,320.00,324.00,336.00. | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ To determine the pharmacokinetics (PK) of PDP-117 when administered as single and multiple oral doses at escalating dose levels in healthy subjects. ââ?¬Â¢ To determine the pharmacodynamics (PD) of PDP-117 when administered as single and multiple oral doses at escalating dose levels in healthy subjects. ââ?¬Â¢ To determine the effect of food on the PK, PD and bioavailability of PDP-117 when administered as single oral doses at escalating dose levels in healthy subjects.Timepoint: PD sampling time points (Insulin and C-peptide test) for MRD Cohorts : ââ?¬Â¢ 0.00 and 336.00 hours (time points are mentioned post day 1 dose). ââ?¬Â¢ About 3.5 mL blood will be collected at 0.00 hours. ââ?¬Â¢ As the 336.00 hours sampling time point coincides with safety sample at 336.00 hours, blood sample will not be collected separately for PD analysis. | — |
Countries
India
Contacts
Public ContactDr Rajeev M Patil
Norwich Clinical Services Pvt. Ltd.
Outcome results
None listed