A Phase 1, First-in-human, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 After SAD and MAD in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- DWP213388
- Conditions
- Healthy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 72
- Primary Endpoint
- TEAE
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects
Detailed Description
DWP213388 will be administered to the study subjects, according to a randomized, double-blind, and placebo-controlled design. The administration will be a single or multiple oral doses for healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing to sign an Institutional Review Board (IRB) approved informed consent form (ICF) on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any screening procedure being undertaken.
- •Healthy adult male or female subject, of any race, between 18 to 65 years of age, inclusive at time of signing the ICF and prior to study intervention administration.
- •Body mass index (BMI) between 18.0 and 34.9 kg/m2 at Screening.
- •Subject who is determined to be in good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs, and clinical laboratory evaluations at Screening or Day -1 as assessed by the Investigator (or designee).
Exclusion Criteria
- •Subject has significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •Subject has fasting blood glucose \> 110 mg/dL (\> 6.1 mmol/L) (confirmed with repeat testing if required) at Screening.
- •Subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note subjects with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- •Subject has a history of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Arms & Interventions
DWP213388
Each cohort, healthy subjects will be administered DWP213388 (6 subjects per each cohort) SAD Cohort 1: DWP213388 x mg QD Cohort 2: DWP213388 x mg QD Cohort 3: DWP213388 x mg QD Cohort 4: DWP213388 x mg QD Cohort 5: DWP213388 x mg QD MAD Cohort 6: DWP213388 x mg QD Cohort 7: DWP213388 x mg QD Cohort 8: DWP213388 x mg QD Cohort 9: DWP213388 x mg QD
Intervention: DWP213388
Placebo
Each cohort, healthy subjects will be administered placebo (2 subjects per each cohort) SAD Cohort 1: Placebo QD Cohort 2: Placebo QD Cohort 3: Placebo QD Cohort 4: Placebo QD Cohort 5: Placebo QD MAD Cohort 6: Placebo QD Cohort 7: Placebo QD Cohort 8: Placebo QD Cohort 9: Placebo QD
Intervention: Placebo
Outcomes
Primary Outcomes
TEAE
Time Frame: up to 7 days from the last dosing
Incidence and severity
12-lead ECG
Time Frame: up to 7 days from the last dosing
PR interval, QRS interval, RR interval, QT interval, and QTcF
Secondary Outcomes
- Cmax(up to 72 hours from the last dosing)
- AUC(up to 72 hours from the last dosing)
- CL/F(up to 72 hours from the last dosing)