Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

NCT03764462 | Completed Phase 1

• 1 other identifier: AD-101BE
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Area under the curve in time plot (AUCinf)

  pre-dose to 96 hours

• Time to reach Cmax

  pre-dose to 96 hours

• Effective half-life

  pre-dose to 96 hours

• Clearance

  pre-dose to 96 hours

• Volume of distribution

  pre-dose to 96 hours

Other Outcomes (1)

• Number of participants with adverse events

  From Day 1 until 40 Days

Study Arms (2)

Raloxifene 60mg to AD-101 45mg

EXPERIMENTAL

Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral

Drug: AD-101 45mg; Drug: Raloxifene 60mg

AD-101 45mg to Raloxifene 60mg

EXPERIMENTAL

Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral

Drug: AD-101 45mg; Drug: Raloxifene 60mg

Interventions

AD-101 45mg DRUG

Raloxifene 45mg tablet

Also known as: AD-101

AD-101 45mg to Raloxifene 60mg; Raloxifene 60mg to AD-101 45mg

Raloxifene 60mg DRUG

Raloxifene 60mg tablet

AD-101 45mg to Raloxifene 60mg; Raloxifene 60mg to AD-101 45mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Addpharma Inc.: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

AD 101; Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Young-Ran Yoon, M.D., Ph.D

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: December 14, 2018
• Primary Completion: January 2, 2019
• Study Completion: February 8, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)