Trial Outcomes & Findings for A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers (NCT NCT00919867)
NCT ID: NCT00919867
Last Updated: 2021-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Results posted on
2021-06-14
Participant Flow
Study consists of 3 treatment periods performed in 6 dosing sequences: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Vyvanse (lisdexamfatamine dimesylate ) single 50 mg dose, and SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered. There is a washout period between each treatment period.
Participant milestones
| Measure |
SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse
SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
|
SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse
SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
|
Vyvanse First, Then SPD503, Then SPD503 + Vyvanse
Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
|
Vyvanse First, Then SPD503 + Vyvanse, Then SPD503
Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
|
SPD503 + Vyvanse First, Then SPD503, Then Vyvanse
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
|
SPD503 + Vyvanse, Then Vyvanse, Then SPD503
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
7
|
7
|
7
|
7
|
7
|
7
|
|
First Intervention
COMPLETED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Washout
STARTED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
Washout
COMPLETED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
Washout
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
Second Intervention
COMPLETED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
Third Intervention
COMPLETED
|
7
|
7
|
6
|
7
|
7
|
6
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse
SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
|
SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse
SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
|
Vyvanse First, Then SPD503, Then SPD503 + Vyvanse
Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
|
Vyvanse First, Then SPD503 + Vyvanse, Then SPD503
Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
|
SPD503 + Vyvanse First, Then SPD503, Then Vyvanse
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
|
SPD503 + Vyvanse, Then Vyvanse, Then SPD503
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
|
|---|---|---|---|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Intervention
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Baseline characteristics by cohort
| Measure |
SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse
n=7 Participants
SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
|
SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse
n=7 Participants
SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
|
Vyvanse First, Then SPD503, Then SPD503 + Vyvanse
n=7 Participants
Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
|
Vyvanse First, Then SPD503 + Vyvanse, Then SPD503
n=7 Participants
Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
|
SPD503 + Vyvanse First, Then SPD503, Then Vyvanse
n=7 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
|
SPD503 + Vyvanse, Then Vyvanse, Then SPD503
n=7 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 6.20 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 8.44 • n=7 Participants
|
34.6 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
26.0 years
STANDARD_DEVIATION 5.29 • n=4 Participants
|
31.9 years
STANDARD_DEVIATION 8.19 • n=21 Participants
|
31.1 years
STANDARD_DEVIATION 4.18 • n=8 Participants
|
30.5 years
STANDARD_DEVIATION 7.41 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
42 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-amphetamine. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Outcome measures
| Measure |
SPD503 Alone
n=40 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=41 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Guanfacine
|
2.55 ng/ml
Standard Deviation 1.03
|
2.97 ng/ml
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=37 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=39 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine
|
104.9 ng*h/ml
Standard Deviation 34.7
|
112.8 ng*h/ml
Standard Deviation 35.7
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=40 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=41 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Guanfacine
|
8.6 hours
Standard Deviation 7.7
|
7.9 hours
Standard Deviation 5.0
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=37 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=39 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
Time of Plasma Half-Life(T 1/2) of Guanfacine
|
23.5 hours
Standard Deviation 10.2
|
21.4 hours
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=41 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=41 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
Cmax of d-Amphetamine
|
36.48 ng/ml
Standard Deviation 7.13
|
36.50 ng/ml
Standard Deviation 6.00
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=41 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=41 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
AUC of d-Amphetamine
|
686.9 ng*h/ml
Standard Deviation 159.8
|
708.4 ng*h/ml
Standard Deviation 137.8
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=41 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=41 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
Tmax of d-Amphetamine
|
4.2 hours
Standard Deviation 1.1
|
3.9 hours
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dosePopulation: PKP
Outcome measures
| Measure |
SPD503 Alone
n=41 Participants
Single 4 mg dose of extended-release Guanfacine HCl
|
SPD503 + Vyvanse
n=41 Participants
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|
|
T 1/2 of d-Amphetamine
|
11.2 hours
Standard Deviation 1.6
|
11.2 hours
Standard Deviation 1.5
|
Adverse Events
SPD503 Alone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Vyvanse Alone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SPD503 + Vyvanse
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SPD503 Alone
n=40 participants at risk
Single 4 mg dose of extended-release Guanfacine HCl
|
Vyvanse Alone
n=41 participants at risk
Single 50 mg dose
|
SPD503 + Vyvanse
n=41 participants at risk
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
5.0%
2/40
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
7.3%
3/41
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
7.3%
3/41
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Dizziness Postural
|
10.0%
4/40
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
2.4%
1/41
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
0.00%
0/41
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
|
Nervous system disorders
Headache
|
7.5%
3/40
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
4.9%
2/41
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
7.3%
3/41
Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
|
Additional Information
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