Healthy Volunteer
Conditions
Brief summary
This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.
Interventions
DRUGdalcetrapib
Single oral radiolabeled dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects, 45 to 65 years of age inclusive * Body mass index (BMI) between 18 and 32 kg/m2 inclusive
Exclusion criteria
* Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject * Clinically significant abnormal laboratory values * Infrequent bowel movements (e.g. less than one movement per 24 h on average) * An intent to father children within 3 months of dosing * Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy) * External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma | up to Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of Metabolic Profile With Enzyme/Transporter Genotypes | approximately 3 months |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm dalcetrapib: Single oral radiolabeled dose | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 4.13 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
Time frame: up to Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma | 37.5 Percentage of Free Thiophenol M1 | Standard Deviation 1.4 |
Secondary
Correlation of Metabolic Profile With Enzyme/Transporter Genotypes
Time frame: approximately 3 months
Population: Data was not collected