None listed
Conditions
Interventions
Intervention1: PBL 1427: The study will consist of six dose groups of eight subjects each in which six subjects will receive a single dose of active treatment (PO) and two subjects will receive placeb
Sponsors
Panacea Biotec Ltd
Panacea Biotec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects to be enrolled in this trial must fulfil all of these criteria: • Sex: male • Age: 18-60 yr old, both inclusive • Having a Body Mass Index (BMI) between 18.5-28 kg / m2 (both inclusive) and body weight not less than 45 kg • 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 • Voluntarily given written informed consent to participate in this study • 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 • Ability and willingness to abstain from alcohol, methylxanthine-containing 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: • Employees of FCRL or PBL • Not willing to use contraceptives (preferably condoms) during sexual activity for the period of 3 months from the date of check-in • History of hypersensitivity and / or intolerance to Dipeptidyl peptidase (DPP)-IV inhibitors or any other related compounds. • History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study. • Clinically abnormal ECG and Chest X-ray. • Physical findings: clinically relevant abnormal physical findings (including body temperature) suggesting underlying pathologies or those which could interfere with the objectives of the study. • Gastrointestinal disorders likely to influence drug absorption including acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heart burn), preceding one week to admission. • Laboratory values that are significantly different than the normal reference range and/or are deemed to be of clinical significance by the investigator • Presence of reactive disease markers of HIV 1 and II, HBsAg,, HCV or VDRL. • Positive for alcohol breath test and/or urine drug screen (barbiturates, benzodiazepines, amphetamine, cocaine, opiates, tetra-hydro cannabinol). • Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. • History of Diabetes Mellitus or intake of any anti-diabetic medication • Diseases: relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, neurological or gastrointestinal diseases. History of depression, psychosis, schizophrenia or any other severe psychiatric diseases, or epilepsy, or any other illness that may interfere with the aim of the study. History of any significant illness in the 4 weeks preceding the screening • Medications: history of intake of any medications including over the counter medications (OTC) during the 4 weeks period prior to dosing with the IMP. • Investigational drug trials: participation in the evaluation of any drug in the 3 months prior to the start of the study (dosing with IMP). • Blood donation: Subjects who, through completion of this study, would have donated and/or lost more than 300 mL of blood in the past 12 weeks Note: In case the blood loss is last sample of the previous study • Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period. • History of drug dependence or alcoholics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine safety and tolerability of PBL 1427 2. To evaluate the pharmacokinetics (PK) of PBL 1427 Timepoint: The subjects will be confined to the unit, approximately 10.5 hours before drug administration and until 48 h post-dose. Subjects will be housed from admission and prior to dosing at FCRL and will be shifted to Sunflag Hospital ICU well advance in time before dosing and will be housed there till discharge. Subsequent follow ups and all laboratory tests (at day 05 to day 09) will be carried out at FCRL screening area in all the cohorts. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine pharmacodynamic markers of PBL 1427 in the study populationTimepoint: The subjects will be confined to the unit, approximately 10.5 hours before drug administration and until 48 h post-dose. Subjects will be housed from admission and prior to dosing at FCRL and will be shifted to Sunflag Hospital ICU well advance in time before dosing and will be housed there till discharge. Subsequent follow ups and all laboratory tests (at day 05 to day 09) will be carried out at FCRL screening area in all the cohorts. | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Panacea Biotec Ltd
Outcome results
None listed