Trial Outcomes & Findings for A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers (NCT NCT01363999)

NCT ID: NCT01363999

Last Updated: 2019-12-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: 3 days
• Results posted on: 2019-12-17

Participant Flow

Participant milestones

Measure	Total Study All AE and Demographic Data is listed for the Total Study Population
A: RO5317116/F01 Bilayer Tablet STARTED	24
A: RO5317116/F01 Bilayer Tablet COMPLETED	24
A: RO5317116/F01 Bilayer Tablet NOT COMPLETED	0
B: RO5317116/F03 Bilayer Tablet STARTED	24
B: RO5317116/F03 Bilayer Tablet COMPLETED	24
B: RO5317116/F03 Bilayer Tablet NOT COMPLETED	0
C: RO5317116/ F04 Active-coated Tablet STARTED	24
C: RO5317116/ F04 Active-coated Tablet COMPLETED	24
C: RO5317116/ F04 Active-coated Tablet NOT COMPLETED	0
D: RO4607381/ F49 Tablet STARTED	24
D: RO4607381/ F49 Tablet COMPLETED	24
D: RO4607381/ F49 Tablet NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

Baseline characteristics by cohort

Measure	Total Study n=24 Participants All AE and Demographic Data is listed for the Total Study Population
Age, Continuous	27.1 years STANDARD_DEVIATION 9.77 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Outcome measures

Measure	A, RO5317116/F01 Bilayer Tablet n=24 Participants RO5317116/F01 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	B, RO5317116/F03 Bilayer Tablet n=24 Participants RO5317116/F03 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	C, RO5317116/F04 Active-coated Tablet n=24 Participants RO5317116/F04 active-coated tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	D, RO4607381/F49 Tablet n=24 Participants RO4607381/F49 tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1
Plasma Concentration of Dalcetrapib Active Form	285 ng/mL Geometric Coefficient of Variation 68.2	272 ng/mL Geometric Coefficient of Variation 61.9	294 ng/mL Geometric Coefficient of Variation 42	231 ng/mL Geometric Coefficient of Variation 55.9

PRIMARY outcome

Timeframe: 3 days

Outcome measures

Measure	A, RO5317116/F01 Bilayer Tablet n=24 Participants RO5317116/F01 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	B, RO5317116/F03 Bilayer Tablet n=24 Participants RO5317116/F03 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	C, RO5317116/F04 Active-coated Tablet n=24 Participants RO5317116/F04 active-coated tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	D, RO4607381/F49 Tablet n=24 Participants RO4607381/F49 tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1
Plasma Concentration of Atorvastatin	3.56 ng/mL Geometric Coefficient of Variation 46.5	3.55 ng/mL Geometric Coefficient of Variation 50.8	4.26 ng/mL Geometric Coefficient of Variation 60.8	3.86 ng/mL Geometric Coefficient of Variation 61.2

SECONDARY outcome

Timeframe: 3 days

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

Outcome measures

Measure	A, RO5317116/F01 Bilayer Tablet n=24 Participants RO5317116/F01 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	B, RO5317116/F03 Bilayer Tablet n=24 Participants RO5317116/F03 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	C, RO5317116/F04 Active-coated Tablet n=24 Participants RO5317116/F04 active-coated tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	D, RO4607381/F49 Tablet n=24 Participants RO4607381/F49 tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1
Plasma Concentration of Atorvastatin Metabolites	2.50 ng/ml Geometric Coefficient of Variation 37.2	2.51 ng/ml Geometric Coefficient of Variation 50.7	2.95 ng/ml Geometric Coefficient of Variation 46.9	2.77 ng/ml Geometric Coefficient of Variation 51.5

SECONDARY outcome

Timeframe: 9 weeks

Outcome measures

Measure	A, RO5317116/F01 Bilayer Tablet n=24 Participants RO5317116/F01 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	B, RO5317116/F03 Bilayer Tablet n=24 Participants RO5317116/F03 bilayer tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	C, RO5317116/F04 Active-coated Tablet n=24 Participants RO5317116/F04 active-coated tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1	D, RO4607381/F49 Tablet n=24 Participants RO4607381/F49 tablet atorvastatin: single dose of atorvastatin on day 1 dalcetrapib: single dose of dalcetrapib on day 1
Safety: Incidence of Serious Adverse Events	0 Events	0 Events	0 Events	0 Events

Adverse Events

Total Study

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Total Study n=24 participants at risk All AE and Demographic Data is listed for the Total Study Population. Data was not collected by arm since all interventions contained the same formulation.
Surgical and medical procedures Appendectomy	8.3% 2/24
Surgical and medical procedures Inguinal Hernia Repair	8.3% 2/24
Immune system disorders Seasonal Allergy	16.7% 4/24

Additional Information

Ryan Black

DalCor Pharmaceuticals

Email: rblack@dalcorpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place