Phase 1
Completed N=6
A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
Healthy Volunteer
Source: ClinicalTrials.gov NCT01476267 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma — 37.5 Percentage of Free Thiophenol M1
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma |
37.5 | — |
| SECONDARY Correlation of Metabolic Profile With Enzyme/Transporter Genotypes |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01476267). 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.