Clinical trial NCT05607589: The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. Body mass index (BMI) between 18.0 and 34.9 kg/m2 at Screening.
4. 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:

1. 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).

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2. Subject has fasting blood glucose \> 110 mg/dL (\> 6.1 mmol/L) (confirmed with repeat testing if required) at Screening.
3. 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).
4. 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).

Primary outcomes:
measure: TEAE
timeFrame: up to 7 days from the last dosing
measure: 12-lead ECG
timeFrame: up to 7 days from the last dosing
Secondary outcomes:
measure: Cmax
timeFrame: up to 72 hours from the last dosing
measure: AUC
timeFrame: up to 72 hours from the last dosing
measure: CL/F
timeFrame: up to 72 hours from the last dosing
Other outcomes:
Locations:
Study officials:
affiliation: Parexel
name: Goldwater Ronald
role: PRINCIPAL_INVESTIGATOR
References: