Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: CHF5074 1x; Drug: CHF5074 2x; Drug: CHF5074 3x

• Registration Number: NCT01203384
• Lead Sponsor: CERESPIR

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Subject is judged 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.

Exclusion Criteria

• Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
• Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
• Significant allergic conditions that require medical treatment
• Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
• Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo, oral tablet, multidose
CHF5074 1x	CHF5074 1x	oral tablet, multidose
CHF5074 2x	CHF5074 2x	oral tablet, multidose
CHF5074 3x	CHF5074 3x	oral tablet, multidose

Primary Outcome Measures

Name	Time	Method
Adverse Events	from Screening through Day 18

Secondary Outcome Measures

Name	Time	Method
Dose linearity of CHF5074 plasma levels (Cmax)	Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)	Day -1 through Day 18

Trial Locations

Locations (1)

Iberica Clinical Research Center; 🇺🇸 Eatontown, New Jersey, United States