NCT02174237

A Study to Test the Safety/Tolerability of Increasing Doses of LNP1892 Versus Placebo in Healthy Male/Female Subjects

LNP1892 - A Phase I, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Lupin Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral dose LNP1892 in healthy males and female subjects

Detailed description

This is first in human, Phase 1 study. Primary purpose is to assess safety, tolerability, pharmacodynamic and pharmacokinetic of the LNP1892. Study will be conducted in healthy human subjects. Pharmacokinetic will be studied in the subjects after administration of single and multiple doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LNP1892	Tablets of two strengths (5 and 25 mg)
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-06-25
• Last updated: 2015-04-13

Locations

1 site across 1 country: United Kingdom