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Safety, Pharmacokinetics and Pharmacodynamics Study of Treatment With CHF 5074 in Healthy Young Male Subjects (CT01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00954252
First received: July 31, 2009
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the safety and tolerability of single oral doses of CHF 5074 in young healthy male volunteers.


Condition Intervention Phase
Alzheimer's Disease
Drug: CHF 5074
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF 5074 in Healthy Young Male Subjects

Resource links provided by NLM:


Further study details as provided by Chiesi Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: from Screening through Day +3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose linearity of CHF5074 plasma levels (Cmax and AUC0-t) [ Time Frame: Day -1 through Day +3 ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Article Drug: CHF 5074
1x, oral capsule, single dose
Drug: CHF 5074
2x, oral capsule, single dose
Drug: CHF 5074
4x, oral capsule, single dose
Drug: CHF 5074
8x, oral capsule, single dose
Drug: CHF 5074
16x, oral capsule, single dose
Drug: CHF 5074
24x, oral capsule, single dose
Placebo Comparator: Placebo Drug: placebo
placebo, oral capsule, single dose

Detailed Description:

The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of CHF5074 after single oral administration to young healthy male volunteers.

The secondary objective of this study is to evaluate the pharmacokinetics of CHF5074 after single oral administration to young healthy male volunteers. The secondary endpoint of this study is to verify if CHF5074 plasma levels (Cmax and AUC0-t) increase proportionally with the dose (dose-linearity).

The exploratory objective of this study is to evaluate the pharmacodynamics of CHF5074 after single oral administration to young healthy male volunteers. The respective exploratory endpoint is to assess the relationship between individual maximum CHF5074 plasma concentrations and corresponding A-beta42 plasma concentrations corrected for baseline A-beta42 levels.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject's written informed consent is obtained prior to any study-related procedures.
  • Subject is nonsmoking male between 18 and 45 years of age, inclusive.
  • Subject has a body mass index between 18 and 30 kg/m2, inclusive.
  • Subject is judged, by the investigator, to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests including complete hematology, blood chemistry (glucose, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, albumin, alkaline phosphatase, sodium, potassium), thyroid function, urinalysis (glucose, hemoglobin, blood, proteins, pH) and fecal occult blood.
  • Subject understands the procedures and agrees to participate in the study program.

Exclusion Criteria:

  • Subject is mentally or legally incapacitated.
  • Subject has a history of any illness that, in the opinion of the investigator and according to the protocol, might confound the results of the study or pose additional risk in administering CHF5074 to the subject.
  • Subject has a medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
  • Subject has liver function test abnormalities with elevated AST or ALT greater than or equal to 2 times upper limit of normal and/or elevated bilirubin greater than or equal to 2 times upper limit of normal.
  • Subject has renal function test abnormalities, including serum creatinine greater than 1.8 g/dL.
  • Subject has abnormal fasting serum concentrations of TSH, T3 or T4.
  • Subject has a positive result for fecal occult blood testing performed at screening.
  • Subject has clinically significant abnormalities on physical examination, ECG or laboratory tests carried out at screening.
  • Subject has a history of a psychiatric disorder.
  • Subject has significant allergic conditions that require medical treatment or has known hypersensitivity to medications that could be activated by CHF5074 treatment.
  • Subject is positive on testing for hepatitis B surface antigen, hepatitis C antibody or HIV 1 or 2 antibodies.
  • Subject has donated blood within the 1 month prior to screening.
  • Subject has a history of alcohol or drug abuse in the past 12 months.
  • Subject used any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
  • Subject has used ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
  • Subject has used any other over-the-counter drug within 1 week prior to study drug administration Occasional treatment with acetaminophen or aspirin is permitted but must be reported to the investigator. Vitamins are permitted.
  • Subject is positive on urine drug screening for drugs of abuse (cannabinoids, cocaine, opiates, amphetamines, barbiturates, benzodiazepines).
  • Subject has evidence of alcohol on screening blood work and breathalyzer test.
  • Subject does not agree to use a medically acceptable contraceptive (abstain from sexual intercourse, or use a condom with spermicide) for 7 days after study drug administration, or has not had a vasectomy at least 6 months prior to study participation.
  • Subject is unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments.
  • Subject has participated in another investigational study within 30 days prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954252

Locations
United States, New Jersey
Iberica Clinical Research Center
Eatontown, NJ 07724, New Jersey, United States, 07724
Sponsors and Collaborators
Chiesi Pharmaceuticals Inc.
Investigators
Principal Investigator: Joel S Ross, MD, FACP Iberica Clinical Research Center
  More Information

Publications:

Responsible Party: Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00954252     History of Changes
Other Study ID Numbers: CCD-0814-PR-0008
Study First Received: July 31, 2009
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014