Healthy Volunteer
Conditions
Brief summary
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.
Interventions
DRUGatorvastatin
single dose of atorvastatin on day 1
DRUGdalcetrapib
single dose of dalcetrapib on day 1
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers, 18 to 55 years of age, 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 patient * Clinically significant abnormal laboratory values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Concentration of Dalcetrapib Active Form | 3 days |
| Plasma Concentration of Atorvastatin | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence of Serious Adverse Events | 9 weeks | — |
| Plasma Concentration of Atorvastatin Metabolites | 3 days | Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma. |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Study All AE and Demographic Data is listed for the Total Study Population | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total Study |
|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 9.77 |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Plasma Concentration of Atorvastatin
Time frame: 3 days
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| A, RO5317116/F01 Bilayer Tablet | Plasma Concentration of Atorvastatin | 3.56 ng/mL | Geometric Coefficient of Variation 46.5 |
| B, RO5317116/F03 Bilayer Tablet | Plasma Concentration of Atorvastatin | 3.55 ng/mL | Geometric Coefficient of Variation 50.8 |
| C, RO5317116/F04 Active-coated Tablet | Plasma Concentration of Atorvastatin | 4.26 ng/mL | Geometric Coefficient of Variation 60.8 |
| D, RO4607381/F49 Tablet | Plasma Concentration of Atorvastatin | 3.86 ng/mL | Geometric Coefficient of Variation 61.2 |
Primary
Plasma Concentration of Dalcetrapib Active Form
Time frame: 3 days
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| A, RO5317116/F01 Bilayer Tablet | Plasma Concentration of Dalcetrapib Active Form | 285 ng/mL | Geometric Coefficient of Variation 68.2 |
| B, RO5317116/F03 Bilayer Tablet | Plasma Concentration of Dalcetrapib Active Form | 272 ng/mL | Geometric Coefficient of Variation 61.9 |
| C, RO5317116/F04 Active-coated Tablet | Plasma Concentration of Dalcetrapib Active Form | 294 ng/mL | Geometric Coefficient of Variation 42 |
| D, RO4607381/F49 Tablet | Plasma Concentration of Dalcetrapib Active Form | 231 ng/mL | Geometric Coefficient of Variation 55.9 |
Secondary
Plasma Concentration of Atorvastatin Metabolites
Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.
Time frame: 3 days
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| A, RO5317116/F01 Bilayer Tablet | Plasma Concentration of Atorvastatin Metabolites | 2.50 ng/ml | Geometric Coefficient of Variation 37.2 |
| B, RO5317116/F03 Bilayer Tablet | Plasma Concentration of Atorvastatin Metabolites | 2.51 ng/ml | Geometric Coefficient of Variation 50.7 |
| C, RO5317116/F04 Active-coated Tablet | Plasma Concentration of Atorvastatin Metabolites | 2.95 ng/ml | Geometric Coefficient of Variation 46.9 |
| D, RO4607381/F49 Tablet | Plasma Concentration of Atorvastatin Metabolites | 2.77 ng/ml | Geometric Coefficient of Variation 51.5 |
Secondary
Safety: Incidence of Serious Adverse Events
Time frame: 9 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A, RO5317116/F01 Bilayer Tablet | Safety: Incidence of Serious Adverse Events | 0 Events |
| B, RO5317116/F03 Bilayer Tablet | Safety: Incidence of Serious Adverse Events | 0 Events |
| C, RO5317116/F04 Active-coated Tablet | Safety: Incidence of Serious Adverse Events | 0 Events |
| D, RO4607381/F49 Tablet | Safety: Incidence of Serious Adverse Events | 0 Events |