Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DA-7218; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097043

DA7218_PK_I

Details and patient eligibility

About

This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.

Enrollment: 31 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male Korean 19-45 years
• Body weight:55-90kg, BMI:18.0-27.0

Exclusion criteria

• Present condition or history of any clinically significant disease
• Clinical evidence or history of GI disease or history of GI surgery
• History of hypersensitivities, including drug allergies
• AST (SGOT) or ALT (SGPT) > 1.5 times the upper normal limit
• Systolic blood pressure : <100 mmHg or >160 mmHg
• Diastolic blood pressure : <60 mmHg or >100 mmHg
• Drug abuse within 2 months, or a positive reaction to an abusive drug or cotinine
• Taken any ETC or herbal supplement within 2 weeks or any OTC or vitamin supplement within 1 week
• Participation in and administration of IP of another clinical trial within 2 months
• Donation of whole blood within 2 months, or blood components within 1 month, or receipt of blood transfusion within 1 month
• Consumption of more than 21 units of alcohol/week or inability to abstain from drinking during the study period
• Smoking within 3 months
• Taking caffeine- or grapefruit-containing products within 3 days
• Plan to be pregnant, or not to use an appropriate method of contraception

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 6 patient groups, including a placebo group

[Group 1] DA-7218

Experimental group

Description:

200mg, By mouth or orally (PO) \& intravenous(IV) administration

Treatment:

Drug: DA-7218

[Group 1] Placebo

Placebo Comparator group

Description:

Placebo, By mouth or orally (PO) \& intravenous(IV) administration

Treatment:

Drug: Placebo

[Group 2] DA-7218

Experimental group

Description:

400mg, By mouth or orally (PO) administration

Treatment:

Drug: DA-7218

[Group 2] Placebo

Placebo Comparator group

Description:

Placebo, By mouth or orally (PO) administration

Treatment:

Drug: Placebo

[Group 3] DA-7218

Experimental group

Description:

600mg, By mouth or orally (PO) administration

Treatment:

Drug: DA-7218

[Group 3] Placebo

Placebo Comparator group

Description:

Placebo, By mouth or orally (PO) administration

Treatment:

Drug: Placebo