Phase I Single and Multiple Escalating Dose Study of RGN1016 in Healthy Male Subjects

NCT02820155 | Unknown Phase 1 DMC

• 1 other identifier: 201412002MIPD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, placebo-controlled, dose-escalating, single dose and multiple dose study.

Conditions

Healthy

Keywords

Alzheimer's disease,cognitive function

Outcome Measures

Primary Outcomes (1)

• Number of incidence of Adverse Events.

  up to14 days

Secondary Outcomes (4)

• Area under the plasma concentration-time curve (AUC)

  8 days

• Time to peak drug concentration (Tmax)

  8 days

• Maximum Plasma Concentration (Cmax)

  8 days

• Half-life T1/2

  8 days

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Drug: Placebo

RGN1016_50mg

EXPERIMENTAL

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Drug: RGN1016

RGN1016_100mg

EXPERIMENTAL

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Drug: RGN1016

RGN1016_200mg

EXPERIMENTAL

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Drug: RGN1016

RGN1016_400mg

EXPERIMENTAL

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Drug: RGN1016

RGN1016_800mg

EXPERIMENTAL

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Drug: RGN1016

Interventions

RGN1016 DRUG

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

RGN1016_100mg; RGN1016_200mg; RGN1016_400mg; RGN1016_50mg; RGN1016_800mg

Placebo DRUG

Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects may be entered in the study only if they meet all of the following criteria:
• Male with suitable veins for cannulation or repeated venipuncture, and must be able to swallow the study drug intact;
• Aged between 20 and 45 years (inclusive) at the screening visit;
• Has normal hematology results at screening visit;
• WBC: 3.54 \~ 9.06X10\^3/μL
• RBC: 4 \~ 5.52X10\^6/μL
• hemoglobin: 13.2 \~17.2 g/dL
• hematocrit: 40.4 \~ 51.1%
• platelet: 148 \~ 339X10\^3/μL
• Has normal biochemistry results at screening visit;
• alkaline phosphatase: 34 \~ 104 U/L
• total bilirubin: 0.3 \~ 1.0 mg/dL
• AST: 8 \~ 31 U/L
• ALT: 0 \~ 41 U/L
• BUN: 7 \~ 25 mg/dL

You may not qualify if:

• Subjects must not satisfy any of the following criteria:
• Has a body weight less than 50 kg and/or body mass index (BMI) less than 18 kg/m\^2 or greater than 30 kg/m\^2 at the screening visit. Body mass index is determined as total body weight/height\^2 (kg/m\^2);
• Is not in good general health as judged by the Investigator based on medical history, vital signs, physical examination, ECG, laboratory tests, and urinalysis at the screening visit or prior to administration of investigational product;
• Has a history or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs at the screening visit or prior to administration of investigational product;
• Has a clinically significant psychiatric, renal, hepatic, cardiovascular, gastrointestinal, or neurologic disease at screening or prior to administration of investigational product;
• Is a smoker and/or has used nicotine-containing products within the last 6 months prior to the screening visit;
• Has a history of alcohol and/or drug abuse;
• Participation of any clinical investigation during the last 60 days;
• Blood donation of more than 250 mL within the past 12 weeks;
• Excessive intake of caffeine containing drinks or food (more than 6 units of caffeine per day). One caffeine unit is contained in the following items: 1 (177.4 mL) cup of coffee, 2 (354.9 mL) cans of cola, 1 (354.9 mL) cup of tea, ½ (118.3 mL) cup of energy drink (e.g., PAOLYTA B Liq. or WHISBIH Liq.) or 3 oz of chocolate;
• Use of drugs with enzyme inducing properties such as St. John's Wort within 4 weeks prior to dosing;
• Has used prescription or nonprescription medication (except for occasional use of paracetamol and nasal spray) or herbal remedies or vitamins or minerals within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to dosing;
• Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of study medication;
• Male subjects who are unwilling to use barrier contraception in addition to having their partner use another method of contraception, for the duration of the study and for 3 months after dosing;
• Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV);

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ming-Jang Chiu

  Neurology department of National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Jang Chiu

CONTACT

+886-2-2312-3456; mjchiu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

TW (1)