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

NCT02174237 | Completed Phase 1

• 2 other identifiers: LRP/LNP1892/2014/0012014-000327-24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Phase 1, safety, tolerability, PK, PD

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of single and multiple oral doses of LNP1892 in healthy subjects

  Up to 30 days after last dose

Secondary Outcomes (2)

• To determine the single and multiple oral dose pharmacokinetics of LNP1892 in healthy subjects

  Pre-dose to 72 hours post last dose

• To determine the single and multiple oral dose pharmacodynamics of LNP1892 in healthy subjects.

  Pre-dose to 72 hours post last dose

Other Outcomes (2)

• 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

• 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

Study Arms (2)

LNP1892

EXPERIMENTAL

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

Drug: LNP1892

Placebo

PLACEBO COMPARATOR

Two subjects in each cohort will receive matching placebo.

Drug: Placebo

Interventions

LNP1892 DRUG

Tablets of two strengths (5 and 25 mg)

LNP1892

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lupin Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit Ltd. Springfield House Hyde Street

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Jim Bush, MB ChB, PhD

  Covance

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 25, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

GB (1)