Single Ascending Dose and Multiple Ascending Dose Study of LNP1892
Research type
Research Study
Full title
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
IRAS ID
149344
Contact name
Jim Bush
Contact email
Sponsor organisation
Lupin Limited
Eudract number
2014-000327-24
ISRCTN Number
n/a
Research summary
Parathyroid hormone (PTH) is a chemical produced by body which regulates levels of calcium in the blood. In people with kidney disease or overgrowth of the parathyroid glands too much PTH is produced by the body. This is called hyperparathyroidism and results in high levels of calcium in the blood which in turn can lead to disorders such as brittle bones or hardening of the arteries which significantly increases the risk of heart attacks and heart failure.
LNP1892 is being developed as a treatment for hyperparathyroidism. It works by copying the way that calcium works to reduce PTH production.
This study will be the first time that the study drug will be given to humans. The study is a double-blind, placebo-controlled, ascending single and multiple oral dose study conducted in two parts.
Part A will involve administration of single ascending doses to five treatment groups to investigate the safety, tolerability, study drug levels in the blood and the effect that the drug has on the body in male and female subjects as well as the effect of food on the study drug levels in one treatment for one group.
In part B, subjects will receive multiple doses over 10 days to investigate the safety, tolerability, study drug levels in the blood and the effect the drug has on the body after multiple doses.
All subjects will be aged between 18 and 65 years.
All doses will be administered orally.
In both parts following review of data from earlier groups, it is intended that the dose level will increase between each group.REC name
North East - York Research Ethics Committee
REC reference
14/NE/0042
Date of REC Opinion
13 Mar 2014
REC opinion
Further Information Favourable Opinion