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

NCT ID: NCT02174237

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LNP1892

Dosage Form: Tablet Two Parts. Part A: Single Ascending Dose (SAD) starting with 25 mg (Maximum 5 cohorts). Part B: Multiple Ascending Dose (MAD), 10 days dosing, Maximum 3 cohorts. Six subjects in each cohort will receive LNP1892

Group Type: EXPERIMENTAL

LNP1892

Intervention Type: DRUG

Tablets of two strengths (5 and 25 mg)

Placebo

Two subjects in each cohort will receive matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

LNP1892

Tablets of two strengths (5 and 25 mg)

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lupin Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Bush, MB ChB, PhD

Role: STUDY_DIRECTOR

Covance

Locations

Covance Clinical Research Unit Ltd. Springfield House Hyde Street

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

LRP/LNP1892/2014/001

Identifier Type: -

Identifier Source: org_study_id

2014-000327-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id