A Clinical Pharmacology Study of K-877 Controlled Release Tablet

Dyslipidemias Clinical Trial

Official title:

A Multicenter, Randomized, Active-controlled, Single-blind, 2-Period, 12-Sequence Crossover Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Pemafibrate in Patients With Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079530
• Other study ID #: K-877-CR-01
• Status: Completed
• Phase: Phase 2
• Start date: September 13, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2021
• Source: Kowa Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2020
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF)

2. Men and postmenopausal women.

3. Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.

4. Patients who have clinical laboratory records with fasting serum TG = 150 mg / dL (or = 200 mg / dL if not fasting) within 6 months before written informed consent.

5. Patients with a fasting serum TG = 150 mg / dL at Screening.

Exclusion Criteria:

1. Patients with a fasting serum TG = 500 mg / dL at Screening

2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent

3. Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc)

4. Patients with uncontrolled thyroid disease

5. Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) = 8.0% at Screening

6. Persons with uncontrolled hypertension (SBP = 160 mmHg or DBP = 100 mmHg)

7. Patients with an AST or ALT three times the upper limit at Screening

8. Patients with cirrhosis or those with biliary obstruction

9. Patients with malignant tumor or those who are judged to have a high risk of recurrence

10. Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening

11. Patients with a history of serious drug allergies (anaphylactic shock, etc.)

12. Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety

13. Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks

14. Patients who have been determined inappropriate by the investigator or subinvestigator

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• K-877 IR 0.2 mg/day
K-877 IR 0.1 mg tablet
• K-877 CR 0.4 mg/day
K-877 CR 0.4 mg tablet
• K-877 CR 0.8 mg/day
Two K-877 CR 0.4 mg tablet

Locations

Country	Name	City	State
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: % change from baseline in fasting serum TG(mg/dL)		4 week after administration in each period
Secondary	% change from baseline in fasting HDL-C levels(mg/dL)		4 week after administration in each period
Secondary	% change from baseline in fasting LDL-C levels(mg/dL)		4 week after administration in each period
Secondary	% change from baseline in fasting non-HDL-C levels(mg/dL)		4 week after administration in each period
Secondary	% change from baseline in fasting Total Cholesterol levels(mg/dL)		4 week after administration in each period