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Completed

NCT Number: NCT03704675

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy sterile males
  • BMI 18.0kg/m2 - 27.0 kg/m2
  • No congenital or chronic disease and no pathological symptoms or pathological findings
  • Investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ECG, cardiac ultrasonography, blood science)

Exclusion criteria

  • Has pathological symptoms or pathological findings
  • Has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug
  • SBP>140 or <90 mmhg , DBP>90 or <60mmHg ,Pulse>100
  • No abnormal Clinical Lab findings

Treatment and study plan

TEW-7197

Drug

Administered orally

Other names: Vactosertib

Primary outcomes

  1. Pharmacokinetics:Maximum Concentration (Cmax)

    Time frame: Pre-dose through 24 hours post-dose in each period of the. study

    Maximum Concentration (Cmax)

  2. Pharmacokinetics:Area Under the Concentration Curve (AUC)

    Time frame: Pre-dose through 24 hours post-dose in each period of the. study

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

Sponsors and collaborators

Lead sponsor

MedPacto, Inc.

Industry

Registry information

Official study title

Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2018
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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