A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

NCT01456663 | Completed Phase 1

• 2 other identifiers: CAFQ056A21232011-000748-28
• Study Type: interventional
• Target: 118
• Locations: 3 countries
• Sites: 3

Brief Summary

This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.

Conditions

Hepatic Impairment

Keywords

AFQ056; Hepatic impairment; Hepatic impaired

Outcome Measures

Primary Outcomes (1)

• Measure: Profile of Pharmacokinetics of AFQ056 in each subjects groups

  AUClast, AUCinf, Cmax, Tmax, T1/2, CL/F, Vz/F

  pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 36, 48, 72, 96, 120 hours post-dose

Secondary Outcomes (2)

• Measure: : Number of subjects with adverse event in each group

  From dose administration (day 1) to 13+/- 2 days after the single dose administration

• Measure: Plasma protein binding results of AFQ056 in each groups.

  2 hours after single dose administration

Study Arms (1)

AFQ056

EXPERIMENTAL

Drug: AFQ056

Interventions

AFQ056 DRUG

AFQ056

Eligibility Criteria

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

You may qualify if:

• Groups 1, 2, 3 and 4 (all subjects)
• Male and female Caucasian subjects
• Group 1, 2 and 3 (subjects with hepatic impairment)
• Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening
• Group 4 (healthy subjects)
• Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.

You may not qualify if:

• Groups 1, 2, 3 and 4 (all subjects)
• Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.
• Group 1, 2 and 3 (subjects with hepatic impairment)
• History of drug or alcohol abuse within 3 months prior to screening
• History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.
• Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
• History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3).
• Documented presence of a porto-systemic shunt.
• Documented presence of esophagus varices (stage III or IV).
• Group 4 (healthy subjects)
• History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
• 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 (3)

Novartis Investigative Site

Orlando, Florida, 32809, United States

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Balatonfüred, 8230, Hungary

Location

Related Links

• Results for CAFQ056A2123 can be found on the Novartis Clinical Trial Results website

MeSH Terms

Interventions

mavoglurant

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: October 21, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 8, 2020

Record last verified: 2013-02

Locations

US (1); HU (1); DE (1)