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Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

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: NCT03824171
Recruitment Status : Completed
First Posted : January 31, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Addpharma Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Raloxifene 60mg/Cholecalciferol 800IU Drug: AD-102 Phase 1

Detailed Description:
This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : April 8, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Raloxifene 60mg/Cholecalciferol 800IU to AD-102
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
 Drug: Raloxifene 60mg/Cholecalciferol 800IU
Raloxifene 60mg/Cholecalciferol 800IU tablet

Drug: AD-102
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Experimental: AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
 Drug: Raloxifene 60mg/Cholecalciferol 800IU
Raloxifene 60mg/Cholecalciferol 800IU tablet

Drug: AD-102
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet


Outcome Measures
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Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: pre-dose to 96 hours ]
    Cmax of Raloxifene

  2. Peak Plasma Concentration (Cmax) [ Time Frame: pre-dose to 72 hours ]
    Cmax of corrected Cholecalciferol

  3. Area under the curve in time plot (AUCt) [ Time Frame: pre-dose to 96 hours ]
    AUCt of Raloxifene

  4. Area under the curve in time plot (AUCt) [ Time Frame: pre-dose to 72 hours ]
    AUCt of corrected Cholecalciferol


Secondary Outcome Measures :
  1. Area under the curve in time plot (AUCinf) [ Time Frame: pre-dose to 96 hours ]
    AUCinf of Raloxifene

  2. Area under the curve in time plot (AUCinf) [ Time Frame: pre-dose to 72 hours ]
    AUCinf of Corrected Cholecalciferol

  3. Time to reach Cmax [ Time Frame: pre-dose to 96 hours ]
    Tmax of Raloxifene

  4. Time to reach Cmax [ Time Frame: pre-dose to 72 hours ]
    Tmax of Corrected Cholecalciferol

  5. Effective half-life [ Time Frame: pre-dose to 96 hours ]
    t1/2 of Raloxifene

  6. Effective half-life [ Time Frame: pre-dose to 72 hours ]
    t1/2 of Corrected Cholecalciferol


Other Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: From Day 1 until 32 Days ]
    Incidence rate of adverse events


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
  • The Age between 19 and 50 in healthy male volunteers at the time of screening visit

Exclusion Criteria:

  • As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range
  • As a result of laboratory tests, the following figures: 25-OH vitamin D total <9 ng/mL
Contacts and Locations
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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): NCT03824171


Locations
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Korea, Republic of
Korea University Guro Hosptial
Seoul, Korea, Republic of
Sponsors and Collaborators
Addpharma Inc.
More Information
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Responsible Party: Addpharma Inc.
ClinicalTrials.gov Identifier: NCT03824171    
Other Study ID Numbers: AD-102BE
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Cholecalciferol
Raloxifene Hydrochloride
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
 Vitamins
Micronutrients
Bone Density Conservation Agents
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators