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

A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of different formulations of PBL1427 in Healthy Male Volunteers - PBL 1427

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010857

Enrollment

Registered

2017-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PBL 1427: Dosage: 1.Formulation A: 240 mg- Extended release tablet 2.Formulation B: 220 mg -Immediate release Tablet 3.Formulation C: 100 mg - Immediate release Tablet 4.Formulation

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 3.Pharmacokinetic parameters of Urine Analysis: Rmax, Rmin and Ae(0-t) 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	—

Measure

Time frame

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 3.Pharmacokinetic parameters of Urine Analysis: Rmax, Rmin and Ae(0-t) 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

Measure	Time frame
ï?? To evaluate the pharmacokinetics (PK) of PBL1427 ï?? To determine exploratory Pharmacodynamics markers of PBL1427 in the study population. Timepoint: Blood sampling for pharmacokinetic assessment : 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 Blood sampling for Pharmacodynamics assessment 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	—

Measure

Time frame

ï?? To evaluate the pharmacokinetics (PK) of PBL1427 ï?? To determine exploratory Pharmacodynamics markers of PBL1427 in the study population. Timepoint: Blood sampling for pharmacokinetic assessment : 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 Blood sampling for Pharmacodynamics assessment 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

—

Countries

India

Contacts

Public ContactDr Lalitendu Mohanty

Panacea Biotec Ltd.

lalitendumohanty@panaceabiotec.com

Outcome results