Phase 1
Completed N=24
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
Healthy Volunteer
Source: ClinicalTrials.gov NCT01363999 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Plasma Concentration of Dalcetrapib Active Form — 285; 272; 294; 231 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of Dalcetrapib Active Form |
285; 272; 294; 231 | — |
| PRIMARY Plasma Concentration of Atorvastatin |
3.56; 3.55; 4.26; 3.86 | — |
| SECONDARY Plasma Concentration of Atorvastatin Metabolites |
2.50; 2.51; 2.95; 2.77 | — |
| SECONDARY Safety: Incidence of Serious Adverse Events |
0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01363999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.