NCT01904318

Brief Summary

A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy male volunteer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

July 16, 2013

Last Update Submit

February 11, 2014

Conditions

Healthy

Keywords

malePhase IA dose block-randomizedDouble-blindedPlacebo controlledSingle Dosedose EscalationIDP-73152 mesylateFood EffectPharmacokineticshealth male volunteerPDF inhibitor

Outcome Measures

Primary Outcomes (5)

  • Vital signs

    participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

  • Electrocardiography

    participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

  • Clinical laboratory tests

    participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

  • Physical exam

    participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day

  • Adverse event

    participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days

Secondary Outcomes (2)

  • Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D of IDP-73152 mesylate

    Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)

  • Tmax, T1/2, CL/F, CLr of IDP-73152 mesylate

    Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)

Study Arms (7)

IDP-73152 mesylate 40 mg

EXPERIMENTAL
Drug: IDP-73152 mesylate 40 mg

IDP-73152 mesylate 80 mg

EXPERIMENTAL
Drug: IDP-73152 mesylate 80 mg

IDP-73152 mesylate 160 mg

EXPERIMENTAL
Drug: IDP-73152 mesylate 160 mg

IDP-73152 mesylate 320 mg

EXPERIMENTAL
Drug: IDP-73152 mesylate 320 mg

IDP-73152 mesylate 640 mg

EXPERIMENTAL
Drug: IDP-73152 mesylate 640 mg

IDP-73152 mesylate 1280 mg

EXPERIMENTAL
Drug: IDP-73152 mesylate 1280 mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IDP-73152 mesylate 40 mgDRUG

IDP-73152 mesylate 40 mg single dose administration

IDP-73152 mesylate 40 mg
IDP-73152 mesylate 80 mgDRUG

IDP-73152 mesylate 80 mg single dose administration

IDP-73152 mesylate 80 mg
IDP-73152 mesylate 160 mgDRUG

IDP-73152 mesylate 160 mg single dose administration

IDP-73152 mesylate 160 mg
IDP-73152 mesylate 320 mgDRUG

IDP-73152 mesylate 320 mg single dose administration

IDP-73152 mesylate 320 mg
IDP-73152 mesylate 640 mgDRUG

IDP-73152 mesylate 640 mg single dose administration

IDP-73152 mesylate 640 mg
IDP-73152 mesylate 1280 mgDRUG

IDP-73152 mesylate 1280 mg single dose administration

IDP-73152 mesylate 1280 mg
PlaceboDRUG

Placebo single dose administration

Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 20-50 years inclusive, at screening visit.
  • kg ≤ Body weight ≤90kg and body mass index (BMI) between 18.0 - 25.0 kg/m2.
  • Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
  • Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
  • Subject decided to participate voluntarily and gave written Informed consent to comply with the instructions after listening to and fully understanding the detailed explanation about this trial.

You may not qualify if:

  • Subject has clinically significant liver, kidney, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular disease or psychiatric disease (mood disorder, compulsive disorder etc.) or such medical history (including subject with hepatitis virus in case of liver disease).
  • Subject has history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or gastrointestinal surgery (except simple appendectomy or hernia operation) that can affect the absorption of the study drug.
  • Subject has hypersensitivity reaction to drug (aspirin, antibiotics etc.) or history of clinically significant hypersensitivity reaction.
  • Specific laboratory values at screening including: AST(SGOT) and/or ALT \> 1.25 times the upper limit of normal; QTc \> 430 ms or clinical significance of abnormal electrocardiographic patterns.
  • Uncontrolled hypertension defined as sustained systolic blood pressure (SBP) \< 90 mmHg or \> 150 mmHg or diastolic BP (DBP) \< 60 mmHg or \> 110 mmHg at screening evaluation.
  • History of recent tobacco abuse in the past 3 months.
  • Subject took any prescribed drug or oriental medicine within 2 weeks prior to the first medication or any over-the-counter (OTC) drug or vitamins within 1 week prior to the first medication (however, the subject can be included if other criteria are met according to the discretion of the investigator).
  • Use of an investigational drug or treatment in past 2months
  • Subject donated whole blood within 2 months prior to the first medication or apheresis within 1 month prior to the first medication or received blood transfusion within 1 month prior to the first medication.
  • Subject continually drinks (in excess of 21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from drinking through the study period.
  • History of recent tobacco abuse (within 3 months)
  • Subject took grapefruit/caffeine-containing food within 3 days prior to the first medication, or cannot abstain from taking during the hospitalization period.
  • Subject was judged not to be eligible according to the discretion of the investigator for other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Jongno-gu, Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

IDP-73152

Study Officials

  • Kyoung Sang you, MD, PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 22, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations

KR(1)