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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174237
• Other study ID #: LRP/LNP1892/2014/001
• Secondary ID: 2014-000327-24
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2014
• Last updated: April 10, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Lupin Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects will be; males or females (Group A3 only), of any ethnic origin, between 18 and 65 years of age (both inclusive)

• Subjects will have a body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive

• Subjects must be in good health, as determined by; medical history, physical examination, vital sign assessment, 12-lead electrocardiogram (ECG)

• Clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is not acceptable)

• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

• Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception until 3 months after the final dosing occasion.

• Female subjects who are of child-bearing potential; or those with tubal ligation.

• Subjects who have donated; blood in the 3 months prior to screening, plasma in the 7 days prior to screening, platelets in the 6 weeks prior to screening

• Subjects who;consume alcohol, cigarettes, tobacco and have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator

• Subjects who have used any non-prescribed systemic or topical medication, herbal remedies, Vitamin supplements, mineral supplements within 7 days of the first dose administration.

• Subjects who have received any medications, within 30 days of the first dose administration, or any prescribed systemic or topical medication within 14 days of the first dose administration

• Subjects who have an abnormality in heart rate, blood pressure, temperature or respiration rate.

• Subjects with; a positive urine drug screen, a positive alcohol breath test result at screening or first admission.

• Subjects who have an abnormality in the 12-lead ECG.

• Female subjects who are pregnant or lactating

• Subjects who are participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug (new molecular entity) in the past 3 months.

• Subjects with a significant history of drug allergy to similar drug or its excipients.

• Subjects who have any clinically significant medical history or significant allergic condition in the opinion of the investigator

• Subjects with clinically significant out of range PTH or serum calcium or vitamin D levels as judged by the investigator. Subjects with current or a history of hypocalcaemia

• Subjects who; are known to have serum hepatitis, are carriers of the hepatitis B surface antigen (HBsAg) are carriers of the hepatitis C antibody, have a positive result to the test for HIV antibodies.

• Subjects who have previously taken part in or withdrawn from this study post first drug administration.

• Other standard exclusion criteria like Subjects who have a clinically significant disorder or a significant abnormal laboratory finding, in the opinion of the Investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LNP1892
Tablets of two strengths (5 and 25 mg)
• Placebo
Matching placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd. Springfield House Hyde Street	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Lupin Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Objectives: To determine the effect of food on the single oral dose pharmacokinetics of LNP1892 in healthy subjects		Pre-dose to 72 hours post last dose	No
Other	Exploratory Objectives: To determine the effect of gender on the single oral dose pharmacokinetics of LNP1892 in healthy subjects		Pre-dose to 72 hours post last dose	No
Primary	To determine the safety and tolerability of single and multiple oral doses of LNP1892 in healthy subjects		Up to 30 days after last dose	Yes
Secondary	To determine the single and multiple oral dose pharmacokinetics of LNP1892 in healthy subjects		Pre-dose to 72 hours post last dose	No
Secondary	To determine the single and multiple oral dose pharmacodynamics of LNP1892 in healthy subjects.		Pre-dose to 72 hours post last dose	No