Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dapagliflozin; Drug: DWP16001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03364985

DW_DWP16001001

Details and patient eligibility

About

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.

Enrollment: 123 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male adults aged 19 to 50 at the time of screening test.
2. Body weight between 50.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 and 27.0.
3. Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study.
4. Eligible to participate in the study by discretion of the investigator following medical examination by interview, physical examination, and clinical examination.

Exclusion criteria

1. Presence of a clinically significant hepatic, renal, nervous, respiratory, endocrine, blood•tumor, cardiovascular, urogenital, psychiatric disorder or prior history.

2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of surgery (except for simple appendectomy or hernia surgery) that may affect safety and PK/PD assessment.

3. Hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.

4. Following laboratory abnormalities identified during the screening test:

   • AST (SGOT), ALT (SGPT) >1.5 upper limit of normal range
   • Creatinine clearance calculated by the MDRD equation < 90 mL/min
   • Repeatedly confirmed QTc interval > 450 ms
   • Fasting serum glucose > 110mg/dL or < 70mg/dL
   • Serum HbA1c > 6.5 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 10 patient groups

Cohort 1: DWP16001 Amg

Experimental group

Description:

DWP16001 Amg, tablets, orally, single dose administration

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 2: DWP16001 Bmg

Experimental group

Description:

DWP16001 Bmg, tablets, orally, single dose administration

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 3: DWP16001 Cmg

Experimental group

Description:

DWP16001 Cmg, tablets, orally, single dose administration

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 4: DWP16001 Dmg

Experimental group

Description:

DWP16001 Dmg, tablets, orally, single dose administration

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 5: DWP16001 Emg

Experimental group

Description:

DWP16001 Emg, tablets, orally, single dose administration

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 6: DWP16001 Fmg

Experimental group

Description:

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 7: DWP16001 Gmg

Experimental group

Description:

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 8: DWP16001 Hmg

Experimental group

Description:

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 9: DWP16001 Img

Experimental group

Description:

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin

Cohort 10: DWP16001 Jmg

Experimental group

Description:

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Treatment:

Drug: DWP16001

Drug: Placebo

Drug: Dapagliflozin