Pharmacokinetics of LCQ908 in Patients With Renal Impairment

NCT01558323 | Completed Phase 1

• 1 other identifier: CLCQ908B2102
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects

Conditions

Renal Impairment

Keywords

LCQ908, Renal Impairment, Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

• Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

• Maximum plasma concentration (Cmax) of LCQ908

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

Secondary Outcomes (8)

• Number of participants with adverse events (AEs), serious adverse events (SAEs) and death

  Day 29

• The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

• Time to maximum plasma concentration of LCQ908

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

• The time required for the concentration of the drug to reach half of its original value

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

• Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration

  Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing

Study Arms (3)

LCQ908 (mild renal impairment plus healthy volunteers)

EXPERIMENTAL

Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with mild renal impairment and will receive a single 40 mg dose of LCQ908.

Drug: LCQ908

LCQ908 (moderate renal impairment plus healthy volunteers)

EXPERIMENTAL

Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with moderate renal impairment and will receive a single 40 mg dose of LCQ908.

Drug: LCQ908

LCQ908 (severe renal impairment plus healthy volunteers)

EXPERIMENTAL

Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with severe renal impairment and will receive a single 40 mg dose of LCQ908.

Drug: LCQ908

Interventions

LCQ908 DRUG

Participants will receive a single oral dose of LCQ908

LCQ908 (mild renal impairment plus healthy volunteers); LCQ908 (moderate renal impairment plus healthy volunteers); LCQ908 (severe renal impairment plus healthy volunteers)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with renal impairment only
• Estimated Creatinine Clearance (CLcr) by the Cockroft-Gault equation ≤80mL/min;
• Mild renal impairment defined as CLcr 50-80 mL/min
• Moderate renal impairment defined as CLcr 30-50 mL/min
• Severe renal impairment defined as CLcr \<30 mL/min
• Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation \>80mL/min

You may not qualify if:

• All Individuals
• A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
• Female subjects must be of non child bearing potential or use an effective method of contraception.
• Individuals with renal impairment
• Renal transplant at any time.
• Subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months.
• History of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days.
• Any medication that is contraindicated in moderate or severe renally impaired population
• Healthy subjects
• History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria)
• Evidence of urinary obstruction or difficulty in voiding at screening
• History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Orlando, Florida, 32809, United States

Location

Novartis Investigative Site

Knoxville, Tennessee, 37920, United States

Location

Related Links

• Results for CLCQ908B2102 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Renal Insufficiency

Interventions

pradigastat

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 20, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 19, 2020

Record last verified: 2014-01

Locations

US (2)