NCT00919867

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

June 24, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2009

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 2, 2010

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1 month

First QC Date

June 10, 2009

Results QC Date

July 1, 2010

Last Update Submit

June 10, 2021

Conditions

Healthy

Keywords

Normal, healthy volunteers (for this Phase 1 study)

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

Study Arms (3)

A: SPD503 (4mg)

ACTIVE COMPARATOR
Drug: SPD503

B: VYVANSE (50mg)

ACTIVE COMPARATOR
Drug: VYVANSE

C: SPD503 (4mg) + VYVANSE (50mg)

ACTIVE COMPARATOR
Drug: SPD503 and VYVANSE

Interventions

SPD503DRUG

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.

Also known as: guanfacine hydrochloride
A: SPD503 (4mg)
VYVANSEDRUG

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.

Also known as: lisdexamfatamine dimesylate (LDX)
B: VYVANSE (50mg)
SPD503 and VYVANSEDRUG

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.

C: SPD503 (4mg) + VYVANSE (50mg)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Biomedical Research, Inc.

Hackensack, New Jersey, United States

Location

Related Publications (1)

  • Roesch B, Corcoran ME, Fetterolf J, Haffey M, Martin P, Preston P, Purkayastha J, Wang P, Ermer J. Pharmacokinetics of coadministered guanfacine extended release and lisdexamfetamine dimesylate. Drugs R D. 2013 Jun;13(2):119-28. doi: 10.1007/s40268-013-0014-8.

    PMID: 23615868RESULT

MeSH Terms

Interventions

GuanfacineLisdexamfetamine Dimesylate

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsDextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAmines

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

June 24, 2009

Primary Completion

July 30, 2009

Study Completion

July 30, 2009

Last Updated

June 14, 2021

Results First Posted

August 2, 2010

Record last verified: 2021-06

Locations

US(1)