NCT01363999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

December 17, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

May 31, 2011

Results QC Date

July 17, 2019

Last Update Submit

December 13, 2019

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • Plasma Concentration of Dalcetrapib Active Form

    3 days

  • Plasma Concentration of Atorvastatin

    3 days

Secondary Outcomes (2)

  • Plasma Concentration of Atorvastatin Metabolites

    3 days

  • Safety: Incidence of Serious Adverse Events

    9 weeks

Study Arms (4)

A

EXPERIMENTAL

RO5317116/F01 bilayer tablet

Drug: atorvastatinDrug: dalcetrapib

B

EXPERIMENTAL

RO5317116/F03 bilayer tablet

Drug: atorvastatinDrug: dalcetrapib

C

EXPERIMENTAL

RO5317116/F04 active-coated tablet

Drug: atorvastatinDrug: dalcetrapib

D

EXPERIMENTAL

RO4607381/F49 tablet

Drug: atorvastatinDrug: dalcetrapib

Interventions

atorvastatinDRUG

single dose of atorvastatin on day 1

ABCD
dalcetrapibDRUG

single dose of dalcetrapib on day 1

ABCD

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers, 18 to 55 years of age, inclusive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

Atorvastatindalcetrapib

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Ryan Black
Organization
DalCor Pharmaceuticals
rblack@dalcorpharma.com

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 17, 2019

Results First Posted

December 17, 2019

Record last verified: 2019-12

Locations

NZ(1)