HealthyPhase 1NCT00901576

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

A Phase 1 study testing SPD503, Concerta and SPD503 + Concerta in people with Healthy, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SPD503, Concerta and SPD503 + Concerta
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 18 May 2009to 6 Jul 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects must be normal healthy adult volunteers with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at the screening visit

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Advanced Biomedical Research, Inc.
Hackensack, New Jersey, 07601

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: SPD503, Concerta, SPD503 + Concerta
Keywords: Healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPD503Drug
Also called Intuniv
SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets
ConcertaDrug
CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.
SPD503 + ConcertaDrug
SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).

Study groups in NCT00901576
Study group	Role	What they receive
SPD503	Experimental	Not described Receives: Drug: SPD503
Concerta	Active comparator	Not described Receives: Drug: Concerta
SPD503 + Concerta	Active comparator	Not described Receives: Drug: SPD503 + Concerta

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of Guanfacine
Measured: 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
Measured: 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
Measured: 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
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Cmax of d-Methylphenidate
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
AUC of d-Methylphenidate
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Tmax of d-Methylphenidate
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
T 1/2 of d-Methylphenidate
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 20096 Jul 2009

First posted14 May 2009 (estimated)
Study start18 May 2009
Primary completion6 Jul 2009
Study completion6 Jul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00901576
Sponsor's protocol ID: SPD503-114
Status last verified: Jun 2021
First submitted: 12 May 2009
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Roesch B, Corcoran M, Haffey M, Stevenson A, Wang P, Purkayastha J, Martin P, Ermer J. Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release. Drugs R D. 2013 Mar;13(1):53-61. doi: 10.1007/s40268-013-0009-5.
PubMed 23519656

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, Three-period Crossover Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD503 and CONCERTA, Administered Alone and in Combination in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT00901576
Acronym / sponsor ID: SPD503-114
Conditions: Healthy
Keywords: Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 18 May 2009 (actual)
Primary completion: 6 Jul 2009 (actual)
Study completion: 6 Jul 2009 (actual)
First posted: 14 May 2009 (estimated)
Results: Posted 19 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
SPD503	Experimental	Drug: SPD503
Concerta	Active comparator	Drug: Concerta
SPD503 + Concerta	Active comparator	Drug: SPD503 + Concerta

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Subjects must be normal healthy adult volunteers with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at the screening visit

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SPD503Also: IntunivSPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets	Drug	SPD503
ConcertaCONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.	Drug	Concerta
SPD503 + ConcertaSPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).	Drug	SPD503 + Concerta

Primary outcome

Maximum Plasma Concentration (Cmax) of Guanfacine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Cmax of d-Methylphenidate
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
AUC of d-Methylphenidate
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Tmax of d-Methylphenidate
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
T 1/2 of d-Methylphenidate
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose

Results and safety

Results posted to the registry on 19 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SPD503 First, Then Concerta, Then SPD503 + Concerta	6	6
SPD503 First, Then SPD503 + Concerta, Then Concerta	7	7
Concerta First, Then SPD503, Then SPD503 + Concerta	7	7
Concerta First, Then SPD503 + Concerta, Then SPD503	6	6
SPD503 + Concerta First, Then SPD503, Then Concerta	6	6
SPD503 + Concerta First, Then Concerta, Then SPD503	6	6

Primary outcome: Maximum Plasma Concentration (Cmax) of Guanfacine

Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: ng/ml

Measure	SPD503 Alone n = 37	SPD503 + Concerta n = 36
Value	2.6 (0.9)	2.7 (0.9)

Population analysed: Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-methylphenidate. 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.

Primary outcome: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine

Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: ng*h/ml

Measure	SPD503 Alone n = 33	SPD503 + Concerta n = 34
Value	96.5 (37.3)	106.7 (39.9)

Population analysed: PKP

Primary outcome: Time of Maximum Plasma Concentration (Tmax) of Guanfacine

Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	SPD503 Alone n = 37	SPD503 + Concerta n = 36
Value	8.1 (8.1)	8.7 (6.3)

Population analysed: PKP

Primary outcome: Time of Plasma Half-Life(T 1/2) of Guanfacine

Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	SPD503 Alone n = 33	SPD503 + Concerta n = 34
Value	20.4 (7.9)	22.7 (10.6)

Population analysed: PKP

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SPD503 Alone	1 of 37 (2.7%)	6 of 37 (16.2%)	Not reported
Concerta Alone	0 of 38 (0%)	8 of 38 (21.1%)	Not reported
SPD503 + Concerta	0 of 37 (0%)	4 of 37 (10.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23519656Roesch B, Corcoran M, Haffey M, Stevenson A, Wang P, Purkayastha J, Martin P, Ermer J. Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release. Drugs R D. 2013 Mar;13(1):53-61. doi: 10.1007/s40268-013-0009-5.
FDA recall informationLink provided by the sponsor.
FDA-approved labelLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPD503, Concerta and SPD503 + Concerta in people with Healthy, run by Shire at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of Guanfacine (time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00901576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.