Trial Outcomes & Findings for Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects (NCT NCT01979185)

Results Overview

AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

30 participants

Primary outcome timeframe

Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Simvastatin First Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.	Simvastatin + SSP-004184SS First Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
Period 1 STARTED	15	15
Period 1 COMPLETED	15	15
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	15	15
Period 2 COMPLETED	15	14
Period 2 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Simvastatin First Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.	Simvastatin + SSP-004184SS First Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
Period 2 Other	0	1

Baseline Characteristics

Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simvastatin First n=15 Participants Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.	Simvastatin + SSP-004184SS First n=15 Participants Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.	Total n=30 Participants Total of all reporting groups
Age, Continuous	39.1 Years STANDARD_DEVIATION 14.97 • n=5 Participants	39.6 Years STANDARD_DEVIATION 15.9 • n=7 Participants	39.3 Years STANDARD_DEVIATION 15.17 • n=5 Participants
Age, Customized <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment UNITED STATES	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.

Population: Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Outcome measures
Measure	Simvastatin Alone n=27 Participants Administered as a single oral 20 mg dose on Day 1.	Simvastatin + SSP-004184SS n=29 Participants Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin	38.142 ng*h/ml Standard Deviation 19.239	26.601 ng*h/ml Standard Deviation 17.864

PRIMARY outcome

Timeframe: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.

Population: Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.

Outcome measures

Outcome measures
Measure	Simvastatin Alone n=29 Participants Administered as a single oral 20 mg dose on Day 1.	Simvastatin + SSP-004184SS n=30 Participants Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin	34.351 ng*h/ml Standard Deviation 18.911	24.019 ng*h/ml Standard Deviation 16.701

PRIMARY outcome

Timeframe: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours.

Population: Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.

Outcome measures

Outcome measures
Measure	Simvastatin Alone n=29 Participants Administered as a single oral 20 mg dose on Day 1.	Simvastatin + SSP-004184SS n=30 Participants Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Maximum Plasma Concentration (Cmax) of Simvastatin	5.006 ng/mL Standard Deviation 3.125	2.72 ng/mL Standard Deviation 1.265

Adverse Events

Simvastatin Alone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Simvastatin + SSP-004184SS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Simvastatin Alone n=29 participants at risk Administered as a single oral 20 mg dose on Day 1.	Simvastatin + SSP-004184SS n=30 participants at risk Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
Nervous system disorders Headache	3.4% 1/29 • Number of events 1	6.7% 2/30 • Number of events 2

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER