Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Raloxifene 60mg/Cholecalciferol 800IU; Drug: AD-102

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Cmax of Raloxifene	pre-dose to 96 hours
Peak Plasma Concentration (Cmax)	Cmax of corrected Cholecalciferol	pre-dose to 72 hours
Area under the curve in time plot (AUCt)	AUCt of Raloxifene	pre-dose to 96 hours
Area under the curve in time plot (AUCt)	AUCt of corrected Cholecalciferol	pre-dose to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve in time plot (AUCinf)	AUCinf of Raloxifene	pre-dose to 96 hours
Area under the curve in time plot (AUCinf)	AUCinf of Corrected Cholecalciferol	pre-dose to 72 hours
Time to reach Cmax	Tmax of Raloxifene	pre-dose to 96 hours
Time to reach Cmax	Tmax of Corrected Cholecalciferol	pre-dose to 72 hours
Effective half-life	t1/2 of Raloxifene	pre-dose to 96 hours
Effective half-life	t1/2 of Corrected Cholecalciferol	pre-dose to 72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Incidence rate of adverse events	From Day 1 until 32 Days

Collaborators and Investigators

• Sponsor: Addpharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Micronutrients; Hormone Antagonists; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Vitamin D; Cholecalciferol; Raloxifene Hydrochloride
• Other Study ID Numbers: AD-102BE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No