PBL 1427, a drug used for Type II diabetes treatment.

Phase 1

Registration Number: CTRI/2017/12/010857

Lead Sponsor: PanaceaBiotec Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Having a Body Mass Index (BMI) between 18.5-28 kg / m2 (both inclusive) and body weight not less than 45 kg

2.Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; and to comply with the requirements of the entire study

3.Voluntarily given written informed consent to participate in this study

4.Be of normal health as determined by the principal investigator from medical history, physical examination and laboratory investigations, 12-lead ECG and X-ray chest of the subjects performed within 10 days prior to the admission of the study

5.Ability and willingness to abstain from alcohol, methyl xanthinecontaining beverages or food (coffee, tea, coke, chocolate, â??power drinksâ??) and grapefruit (juice) from 48 h prior to each admission until study completion.

Exclusion Criteria

Subjects meeting any of these criteria will not be enrolled in the study:

1.Employees of clinical site or Panacea Biotec Limited.

2.Not willing to use contraceptives (preferably condoms) during sexual activity for the period of 3 months from the date of check-in.

3.History of hypersensitivity and / or intolerance to PBL1427or any other related compounds.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Safety and tolerability of different formulations of PBL1427 will be assessed 2.Pharmacokinetic parameters of single doses of PBL1427: Cmax, Tmax, AUC0-t, AUC0-inf, AUC0-24, kel, tÂ½, CL/F and Vz/F <br/ ><br>3.Pharmacokinetic parameters of Urine Analysis: Rmax, Rmin and Ae(0-t) <br/ ><br>Timepoint: Blood samples will be collected for assessment of the exploratory markers Plasma DPP-IV activity and levels of active GLP-1 at Pre-dose, 0.25, 0.50, 1.0, 2.0, 4.0, 8.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 ,84.0, 96.0, 120.0, 144.0 and 168.0 hours post-dose

Secondary Outcome Measures

Name	Time	Method
ï??To evaluate the pharmacokinetics (PK) of PBL1427 <br/ ><br>ï??To determine exploratory Pharmacodynamics markers of PBL1427 in the study population. <br/ ><br>Timepoint: Blood sampling for pharmacokinetic assessment : <br/ ><br>Pre-dose, 0.25, 0.50, 1.0, 2.0, 4.0, 8.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 ,84.0, 96.0, 120.0, 144.0 and 168.0 hours post-dose <br/ ><br>Blood sampling for Pharmacodynamics assessment <br/ ><br>Blood samples will be collected for assessment of the exploratory markers Plasma DPP-IV activity and levels of active GLP-1 at Pre-dose, 0.25, 0.50, 1.0, 2.0, 4.0, 8.0, 16.0, 24.0, 36.0, 48.0, 60.0, 72.0 ,84.0, 96.0, 120.0, 144.0 and 168.0 hours post-dose <br/ ><br>