Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol

NCT02286934 | Completed Phase 1

• 1 other identifier: CYP-CVDL-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol

Conditions

Healthy

Keywords

Carvedilol; CYP2D6; Isoproterenol Sensitivity Test

Outcome Measures

Primary Outcomes (2)

• AUC (area under the plasma concentration-time curve) of carvedilol

  predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

• Cmax (Maximum plasma concentration) of carvedilol

  predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose

Study Arms (1)

Carvedilol

EXPERIMENTAL

* Day 1 to 3 : Carvedilol 12.5 mg qd * Day 4 to 8 : Carvedilol 25 mg qd * Day 9 to 11 : Carvedilol 12.5 mg qd Isoproterenol Sensitivity Test * Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes. * Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes. Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol.

Drug: Carvedilol; Other: Isoproterenol Sensitivity Test

Interventions

Carvedilol DRUG

* Day 1 to 3 : Carvedilol 12.5 mg qd * Day 4 to 8 : Carvedilol 25 mg qd * Day 9 to 11 : Carvedilol 12.5 mg qd

Carvedilol

Isoproterenol Sensitivity Test OTHER

Day 0, 1, 8 : Isoproterenol Sensitivity Test

Carvedilol

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Subjects aged 20 - 45 years
• A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
• Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

You may not qualify if:

• Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
• Subject judged not eligible for study participation by investigator.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Institute of Food and Drug Safety Evaluation, Korea: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

Location

Related Publications (1)

• Jung E, Ryu S, Park Z, Lee JG, Yi JY, Seo DW, Lee J, Jeong HS, Kim JM, Oh WY. Influence of CYP2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamic Characteristics of Carvedilol in Healthy Korean Volunteers. J Korean Med Sci. 2018 May 23;33(27):e182. doi: 10.3346/jkms.2018.33.e182. eCollection 2018 Jul 2.

  PMID: 29962926 DERIVED

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Jae-Yong Chung, MD, PhD

  Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: November 10, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

KR (1)