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CompletedNCT01363999Updated Dec 17, 2019Results posted

A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

A Phase 1 interventional study of atorvastatin and dalcetrapib in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    A

    RO5317116/F01 bilayer tablet

    Drug: atorvastatin · Drug: dalcetrapib

  • Experimental
    B

    RO5317116/F03 bilayer tablet

    Drug: atorvastatin · Drug: dalcetrapib

  • Experimental
    C

    RO5317116/F04 active-coated tablet

    Drug: atorvastatin · Drug: dalcetrapib

  • Experimental
    D

    RO4607381/F49 tablet

    Drug: atorvastatin · Drug: dalcetrapib

Interventions

  • Drugatorvastatin

    single dose of atorvastatin on day 1

  • Drugdalcetrapib

    single dose of dalcetrapib on day 1

06

What researchers measure

Primary outcomes

  1. Plasma Concentration of Dalcetrapib Active Form

    Time frame: 3 days

  2. Plasma Concentration of Atorvastatin

    Time frame: 3 days

Secondary outcomes

  1. Plasma Concentration of Atorvastatin Metabolites

    Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.

    Time frame: 3 days

  2. Safety: Incidence of Serious Adverse Events

    Time frame: 9 weeks

07

Results

Posted Dec 17, 2019

Participant flow

A: RO5317116/F01 Bilayer Tablet
Participant flow — A: RO5317116/F01 Bilayer Tablet
MilestoneTotal Study
Started24
Completed24
Not completed0
B: RO5317116/F03 Bilayer Tablet
Participant flow — B: RO5317116/F03 Bilayer Tablet
MilestoneTotal Study
Started24
Completed24
Not completed0
C: RO5317116/ F04 Active-coated Tablet
Participant flow — C: RO5317116/ F04 Active-coated Tablet
MilestoneTotal Study
Started24
Completed24
Not completed0
D: RO4607381/ F49 Tablet
Participant flow — D: RO4607381/ F49 Tablet
MilestoneTotal Study
Started24
Completed24
Not completed0

Outcome measures

PrimaryPlasma Concentration of Dalcetrapib Active Form
Time frame:
3 days
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Dalcetrapib Active Form
ng/mLA, RO5317116/F01 Bilayer TabletB, RO5317116/F03 Bilayer TabletC, RO5317116/F04 Active-coated TabletD, RO4607381/F49 Tablet
Plasma Concentration of Dalcetrapib Active Form285 ± 68.2272 ± 61.9294 ± 42231 ± 55.9
PrimaryPlasma Concentration of Atorvastatin
Time frame:
3 days
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Atorvastatin
ng/mLA, RO5317116/F01 Bilayer TabletB, RO5317116/F03 Bilayer TabletC, RO5317116/F04 Active-coated TabletD, RO4607381/F49 Tablet
Plasma Concentration of Atorvastatin3.56 ± 46.53.55 ± 50.84.26 ± 60.83.86 ± 61.2
SecondaryPlasma Concentration of Atorvastatin Metabolites

Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.

Time frame:
3 days
Reported as:
Geometric mean · ng/ml
Plasma Concentration of Atorvastatin Metabolites
ng/mlA, RO5317116/F01 Bilayer TabletB, RO5317116/F03 Bilayer TabletC, RO5317116/F04 Active-coated TabletD, RO4607381/F49 Tablet
Plasma Concentration of Atorvastatin Metabolites2.50 ± 37.22.51 ± 50.72.95 ± 46.92.77 ± 51.5
SecondarySafety: Incidence of Serious Adverse Events
Time frame:
9 weeks
Reported as:
Number · Events
Safety: Incidence of Serious Adverse Events
EventsA, RO5317116/F01 Bilayer TabletB, RO5317116/F03 Bilayer TabletC, RO5317116/F04 Active-coated TabletD, RO4607381/F49 Tablet
Safety: Incidence of Serious Adverse Events0000

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Total Study—0/24 (0%)8/24 (33.3%)
Most frequent other events
Most frequent other events
EventTotal Study
Seasonal AllergyImmune system disorders4/24
AppendectomySurgical and medical procedures2/24
Inguinal Hernia RepairSurgical and medical procedures2/24

Baseline characteristics

Age, Continuous
Age, Continuous(years)Total Study
Mean27.1 ± 9.77
Sex: Female, Male
Sex: Female, Male(Participants)Total Study
Female15
Male9
08

Study locations

1 site
  • Christchurch, 8011, New Zealand
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01363999
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jun 2, 2011
Start date
Jun 2011
Primary completion
Jul 2011
Completion
Jul 2011
Results posted
Dec 17, 2019
Last update
Dec 17, 2019

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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