NCT01554293 is a Phase 1 clinical trial of PBL 1427 capsules in Diabetes Mellitus, sponsored by Panacea Biotec Ltd.

Who is sponsoring NCT01554293?

NCT01554293 is sponsored by Panacea Biotec Ltd.

What drugs are being tested in NCT01554293?

Interventions in NCT01554293: Matching placebo, PBL 1427 capsules.

What condition does NCT01554293 study?

NCT01554293 studies Diabetes Mellitus.

Is NCT01554293 still recruiting?

NCT01554293 is currently status unknown. Last updated 15 May 2013.

Last reviewed 2013-05-15 · How we verify

NCT01554293

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled Phase I Study To Determine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Doses Of PBL 1427 In Healthy Volunteers

Status unknown Phase 1 Last updated 15 May 2013

What this trial tests

Phase 1 trial testing Matching placebo in Diabetes Mellitus in 48 participants. Status unknown.

Timeline

1 July 2012

Primary endpoint
1 July 2013

1 September 2013

Quick facts

Lead sponsor	Panacea Biotec Ltd
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	1 July 2012
Primary completion	1 July 2013
Estimated completion	1 September 2013
Sites	1 location across India

Drugs / interventions tested

Matching placebo — full drug profile →
PBL 1427 capsules — full drug profile →

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Panacea Biotec Ltd — full company profile →

Who can join

Adults 18 to 60, male only, with Diabetes Mellitus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of subjects with adverse events
Time frame: Pre-dose and upto Day 5-9
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.
Pharmacokinetics Variables (Cmax, tmax, AUC, t1/2, kel, CL/F & Vz/F)
Time frame: 48 hrs post dose
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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01554293 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Panacea Biotec Ltd
Last refreshed: 15 May 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01554293.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing