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Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects

Sponsor
MedPacto, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03704675
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
2.4
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants in this study will receive 200 milligram (mg) TEW-7197 taken at 7days apart. One dose will be given under fasting . The Other dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 2weeks not including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Through screening (D-30 ~ D-1) prior to the first dose of the investigational product, a total of 16 subjects (Group 1: 8 subjects, Group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. This clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and TEW-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. Pharmacokinetics and safety were evaluated in all subjects according to the planned schedule

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects
Actual Study Start Date :
Aug 8, 2018
Actual Primary Completion Date :
Sep 9, 2018
Actual Study Completion Date :
Oct 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (Fasted->Fed)

Group 1 received a single oral dose in a fasting condition in Period 1, followed by a single oral dose after a high-fat diet in Period 2

Drug: TEW-7197
Administered orally
Other Names:
  • Vactosertib

    		•
    Experimental: Group II(Fed->Fasted)

    Group 2 received a single oral dose after a high-fat diet in Period 1, followed by a single oral in a fasting condition in Period 2

    Drug: TEW-7197
    Administered orally
    Other Names:
  • Vactosertib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics:Maximum Concentration (Cmax) [Pre-dose through 24 hours post-dose in each period of the. study]

      Maximum Concentration (Cmax)

    2. Pharmacokinetics:Area Under the Concentration Curve (AUC) [Pre-dose through 24 hours post-dose in each period of the. study]

      Area Under the Concentration Curve (AUC) of TEW-7197

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Healthy sterile males

    2. BMI 18.0kg/m2 - 27.0 kg/m2

    3. No congenital or chronic disease and no pathological symptoms or pathological findings

    4. Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)

    Exclusion Criteria:

    1. Has pathological symptoms or pathological findings

    2. Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug

    3. SBP>140 or <90 mmhg , DBP>90 or <60mmHg ,Pulse>100

    4. No abnormal Clinical Lab findings

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inje University Busan Paik Hospital Busan Korea, Republic of 47392

    Sponsors and Collaborators

    • MedPacto, Inc.

    Investigators

    • Study Director: Sunjin Hwang, MD, MedPacto, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    MedPacto, Inc.
    ClinicalTrials.gov Identifier:
    NCT03704675
    Other Study ID Numbers:
    • MP-VAC-105
    First Posted:
    Oct 15, 2018
    Last Update Posted:
    Apr 14, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 14, 2020