Pharmacokinetic Drug Interaction Study in Healthy Male Subjects

NCT01426906 | Completed Phase 1

• 1 other identifier: LG-DPCL007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male Volunteers.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (6)

• Cmax

  Until Day 18 or 20

• AUC(last)

  Until Day 18 or 20

• AUC(0-24hr)

  Until Day 18 or 20

• Tmax

  Until Day 18 or 20

• t(1/2beta)

  Until Day 18 or 20

• (6-b-hydrocortisol)/(cortisol) ratio

  Until Day 20

Study Arms (2)

Study A

EXPERIMENTAL

Drug: Ketoconazole

Study B

EXPERIMENTAL

Drug: rifampicin

Interventions

Ketoconazole DRUG

Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole

Study A

rifampicin DRUG

Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin

Study B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a healthy male between 20 and 50 years old
• Has BMI result between 19 and 26 kg/m2 at screening; and a total body weight over 55 kg. BMI(kg/m2) = body weight(kg)/{height(m)}2.
• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Agrees to use an adequate means of contraception during clinical trials

You may not qualify if:

• Subjects with evidence or history of clinically significant hepatic, renal, digestive, neurologic, pulmonary, musculoskeletal, endocrine, hematological, cardiovascular or psychiatric disease
• Subjects with evidence or history of gastrointestinal disease or surgery possibly affecting drug absorption.
• Subjects with history of hypersensitivities or clinically significant adverse events caused by DPPIV inhibitors, ketoconazole, rifampicin, and other drugs
• Subjects who have donated a unit of blood within 60 days or blood components within 30 days before the first administration of the investigational product.
• Subjects who consume excessive alcohol or caffeine; who excessively smoke

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Noh YH, Lim HS, Jin SJ, Kim MJ, Kim YH, Sung HR, Choi HY, Bae KS. Effects of ketoconazole and rifampicin on the pharmacokinetics of gemigliptin, a dipeptidyl peptidase-IV inhibitor: a crossover drug-drug interaction study in healthy male Korean volunteers. Clin Ther. 2012 May;34(5):1182-94. doi: 10.1016/j.clinthera.2012.04.001. Epub 2012 Apr 24.

  PMID: 22534255 DERIVED

MeSH Terms

Interventions

Ketoconazole; Rifampin

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 1, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 1, 2011

Record last verified: 2011-08

Locations

KR (1)