A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and VYVANSE, Administered Alone and in Combination in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919867

Enrollment

Registered

2009-06-12

Start date

2009-06-24

Completion date

2009-07-30

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Normal, healthy volunteers (for this Phase 1 study)

Brief summary

Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.

Interventions

DRUGSPD503

SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

DRUGVYVANSE

VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

DRUGSPD503 and VYVANSE

SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects must be normal healthy adult volunteers (with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at screening) in order to be eligible to participate.

Design outcomes

Primary

Measure	Time frame
Maximum Plasma Concentration (Cmax) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Time of Maximum Plasma Concentration (Tmax) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Time of Plasma Half-Life(T 1/2) of Guanfacine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Tmax of d-Amphetamine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
T 1/2 of d-Amphetamine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Cmax of d-Amphetamine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
AUC of d-Amphetamine	0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
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	7
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	7
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	7
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	7
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	7
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	7
Total	42

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
First Intervention	Physician Decision	0	0	0	0	0	1
First Intervention	Withdrawal by Subject	0	0	1	0	0	0

Baseline characteristics

Characteristic	SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse	Vyvanse First, Then SPD503, Then SPD503 + Vyvanse	Vyvanse First, Then SPD503 + Vyvanse, Then SPD503	SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse	SPD503 + Vyvanse First, Then SPD503, Then Vyvanse	SPD503 + Vyvanse, Then Vyvanse, Then SPD503	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	7 Participants	7 Participants	7 Participants	7 Participants	7 Participants	7 Participants	42 Participants
Age, Continuous	28.7 years STANDARD_DEVIATION 8.44	34.6 years STANDARD_DEVIATION 10.18	26.0 years STANDARD_DEVIATION 5.29	30.9 years STANDARD_DEVIATION 6.2	31.9 years STANDARD_DEVIATION 8.19	31.1 years STANDARD_DEVIATION 4.18	30.5 years STANDARD_DEVIATION 7.41
Region of Enrollment United States	7 Participants	7 Participants	7 Participants	7 Participants	7 Participants	7 Participants	42 Participants
Sex: Female, Male Female	1 Participants	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	9 Participants
Sex: Female, Male Male	6 Participants	5 Participants	5 Participants	6 Participants	5 Participants	6 Participants	33 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	9 / 40	6 / 41	6 / 41
serious Total, serious adverse events	0 / 40	0 / 41	0 / 41