Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: AD-101 45mg; Drug: Raloxifene 60mg

Detailed Description

This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

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

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy Adult aged 19 and more at the time of screening visit
• Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
• No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination

Exclusion Criteria:

• Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
• History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
• As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range

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 to AD-101 45mg; Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral	Drug: AD-101 45mg; Raloxifene 45mg tablet; Other Names: AD-101; Drug: Raloxifene 60mg; Raloxifene 60mg tablet
Experimental: AD-101 45mg to Raloxifene 60mg; Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral	Drug: AD-101 45mg; Raloxifene 45mg tablet; Other Names: AD-101; Drug: Raloxifene 60mg; Raloxifene 60mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Cmax of the total ingredient of AD-101	pre-dose to 96 hours
Area under the curve in time plot (AUCt)	AUCt of the total ingredient of AD-101	pre-dose to 96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve in time plot (AUCinf)	AUCinf of the total ingredient of AD-101	pre-dose to 96 hours
Time to reach Cmax	Tmax of the total ingredient of AD-101	pre-dose to 96 hours
Effective half-life	t1/2 of the total ingredient of AD-101	pre-dose to 96 hours
Clearance	CL/F of the total ingredient of AD-101	pre-dose to 96 hours
Volume of distribution	Vd/F of the total ingredient of AD-101	pre-dose to 96 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 40 Days

Collaborators and Investigators

• Sponsor: Addpharma Inc.
• Investigators: Principal Investigator: Young-Ran Yoon, M.D., Ph.D, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): January 2, 2019
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

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; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; CCR5 Receptor Antagonists; Raloxifene Hydrochloride; AD 101
• Other Study ID Numbers: AD-101BE

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