Study Of Single Ascending Doses Of PBL 1427 In Healthy Volunteers

NCT01554293 | Unknown Phase 1 DMC

• 1 other identifier: PBL/CR/2011/05/CT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

PBL 1427 is a Dipeptidyl peptidase (DPP)-IV inhibitor being developed for treatment of type 2 diabetes. Although a number of DPP-IV inhibitors have been described, there still exists a need for new DPP-IV inhibitors that have better half-life, advantageous potency, stability and selectivity, less toxicity and/or better pharmacodynamic properties.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Number of subjects with adverse events

  Safety and tolerability of PBL 1427 will be assessed after single ascending doses when administered alone on the basis of AEs, vital signs (BP, pulse rate, and body temperature), ECG, laboratory parameters and clinical assessment.

  Pre-dose and upto Day 5-9

• Pharmacokinetics Variables (Cmax, tmax, AUC, t1/2, kel, CL/F & Vz/F)

  Pharmacokinetic parameters of single ascending doses of PBL 1427 : For each subject, blood will be collected at the following time points: pre-dose, 0.25, 0.50, 0.75 1, 1.5, 2, 3, 4, 6, 8, 10, 14, 16, 20, 24, 36 and 48 h post-dose.

  48 hrs post dose

Secondary Outcomes (2)

• Pharmacodynamics assessment (glucose, insulin, C-peptide, lactic acid)

  Pre-dose and upto 4 h post-dose

• Exploratory markers (plasma DPP-IV activity and GLP-1 levels)

  Pre-dose and upto 48 h after dosing

Study Arms (2)

PBL 1427 capsules

EXPERIMENTAL

Drug: PBL 1427 capsules

Matching placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Interventions

Matching placebo DRUG

Matching Placebo, single dose

Matching placebo

PBL 1427 capsules DRUG

PBL 1427 capsules 20 mg and 150 mg, single dose

PBL 1427 capsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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, "power drinks") and grapefruit (juice) from 48 h prior to each admission until study completion

You may not qualify if:

• 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).

Sponsors & Collaborators

• Panacea Biotec Ltd: lead

Study Sites (1)

Fortis Clinical Research Ltd

Faridabad, Haryana, 121 002, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dr Deepak C Chilkoti

  Head-Clinical Operations

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Deepak C Chilkoti

CONTACT

+91-129-4090 900; Deepak.chilkoti@fortis-cro.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 14, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

IN (1)