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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03704675

Enrollment

Registered

2018-10-15

Start date

2018-08-08

Completion date

2018-10-20

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

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

Interventions

DRUGTEW-7197

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics:Maximum Concentration (Cmax)	Pre-dose through 24 hours post-dose in each period of the. study	Maximum Concentration (Cmax)
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026