CT03

CompletedPhase 1

Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

Randomized, Balanced, Single Dose, Cross-Over Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

Lead sponsor

CERESPIR

Asset

CHF 5074

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-45•Male

Primary endpoints

•Area under the curve of plasma CHF 5074 levels from 0•Peak CHF 5074 plasma concentration (Cmax)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCCD-1013-PR-0052

NCT IDNCT01258452

Timeline

Milestones

Study first posted2010-12-13estimated

Study start2011-02 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (month precision)

Last update posted2015-02-10estimated

Assets

Drug assets

CHF 5074

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexMale

Healthy volunteersAccepted

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.

•Subject has a body mass index between 18 and 30 kg/m^2, inclusive

Exclusion criteria

•Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.

•Abnormal result 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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)

Time frame:from Day 1 to Day 5

concentration, descriptive

Primary/protocol endpoint

peak CHF 5074 plasma concentration (Cmax)

Time frame:from Day 1 to Day 5

concentration, descriptive

Secondary/protocol endpoint

the time of occurrence of Cmax (Tmax)

Time frame:from Day 1 to Day 5

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.