Effect of Food on the Pharmacokinetics of TEW-7197 in Healthy Subjects
Clinical Trial for the Safety, Tolerability, and Pharmacokinetics of TEW-7197 Under Fed or Fasting in Healthy Male Subjects
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Aug 2018
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2018
CompletedFirst Submitted
Initial submission to the registry
October 10, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2018
CompletedApril 14, 2020
April 1, 2020
1 month
October 10, 2018
April 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics:Maximum Concentration (Cmax)
Maximum Concentration (Cmax)
Pre-dose through 24 hours post-dose in each period of the. study
Pharmacokinetics:Area Under the Concentration Curve (AUC)
Area Under the Concentration Curve (AUC) of TEW-7197
Pre-dose through 24 hours post-dose in each period of the. study
Study Arms (2)
Group I (Fasted->Fed)
EXPERIMENTALGroup 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
Group II(Fed->Fasted)
EXPERIMENTALGroup 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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedPacto, Inc.lead
Study Sites (1)
Inje University Busan Paik Hospital
Busan, 47392, South Korea
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Sunjin Hwang, MD
MedPacto, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2018
First Posted
October 15, 2018
Study Start
August 8, 2018
Primary Completion
September 9, 2018
Study Completion
October 20, 2018
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share