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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02174237
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Lupin Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: LNP1892 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: 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
Drug: LNP1892
Tablets of two strengths (5 and 25 mg)

Placebo Comparator: Placebo
Two subjects in each cohort will receive matching placebo.
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. To determine the safety and tolerability of single and multiple oral doses of LNP1892 in healthy subjects [ Time Frame: Up to 30 days after last dose ]

Secondary Outcome Measures :
  1. To determine the single and multiple oral dose pharmacokinetics of LNP1892 in healthy subjects [ Time Frame: Pre-dose to 72 hours post last dose ]
  2. To determine the single and multiple oral dose pharmacodynamics of LNP1892 in healthy subjects. [ Time Frame: Pre-dose to 72 hours post last dose ]

Other Outcome Measures:
  1. Exploratory Objectives: To determine the effect of food on the single oral dose pharmacokinetics of LNP1892 in healthy subjects [ Time Frame: Pre-dose to 72 hours post last dose ]
  2. Exploratory Objectives: To determine the effect of gender on the single oral dose pharmacokinetics of LNP1892 in healthy subjects [ Time Frame: Pre-dose to 72 hours post last dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • Other standard exclusion criteria like Subjects who have a clinically significant disorder or a significant abnormal laboratory finding, in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174237


Locations
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United Kingdom
Covance Clinical Research Unit Ltd. Springfield House Hyde Street
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Lupin Ltd.
Investigators
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Study Director: Jim Bush, MB ChB, PhD Covance
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Responsible Party: Lupin Ltd.
ClinicalTrials.gov Identifier: NCT02174237    
Other Study ID Numbers: LRP/LNP1892/2014/001
2014‐000327‐24 ( EudraCT Number )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: April 2015
Keywords provided by Lupin Ltd.:
Phase 1, safety, tolerability, PK, PD