HealthyPhase 1NCT01235338

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers

A Phase 1 study testing LDX + Venlafaxine XR and Venlafaxine XR + LDX 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LDX + Venlafaxine XR and Venlafaxine XR + LDX
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2010to 17 Jan 2011
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

Age 18-45 years
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
Male, or
Non-pregnant, non-lactating female
Females must be at least 90 days post partum or nulliparous.
Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test

Show all 10Show fewer

Satisfactory medical assessment
Ability to provide information on family history of hypertension.
Body Mass Index (BMI) between 18.5 and 30.0kg/m² inclusive.
Ability to swallow all investigational products.

Who cannot join

Current or recurrent disease (e.g., cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions)
Current or relevant previous history of physical or psychiatric illness.
Significant illness.
History of significant anxiety, tension, or agitation as assessed by the Investigator.
History of or current diagnosis of glaucoma.
History of a seizure disorder (other than infantile febrile seizures), any tic disorder or a current diagnosis and/or known family history of Tourette's Disorder.

Show all 19Show fewer

History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke, or other serious cardiac problems.
History of controlled or uncontrolled hypertension or a resting sitting systolic BP >139mmHg or diastolic BP >89mmHg.
Known family history of sudden cardiac death or ventricular arrhythmia.
Suicidal ideation or any lifetime history of suicidal behavior.
Consumption of alcohol, Seville oranges, grapefruit, or any grapefruit containing products within 7 days of first dose of investigational product.
Current use of any medication (including prescription, over the counter [OTC], herbal or homeopathic preparations or supplements) with the exception of the occasional dose of acetaminophen, or hormonal contraceptives.
History of alcohol or other substance abuse within the last year.
A positive screen for alcohol or drugs of abuse.
Male subjects who consume more than 21 units of alcohol per week or 3 units per day. Female subjects who consume more than 14 units of alcohol per week or 2 units per day. [1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1.5oz) = 0.75oz alcohol]
A positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody screen.
Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product.
Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6oz. cup of coffee, two 12oz. cans of cola, one 12oz. cup of tea, three 1oz. chocolate bars, or one 8oz. serving of an energy drink. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).
Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami
Miami, Florida, 33014

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD489 and EFFEXOR XR, Administered Alone and in Combination in Healthy Adult Subjects

This study will examine the effects of co-administration of SPD489 and the antidepressant EFFEXOR XR on the pharmacokinetics of lisdexamfetamine, d-amphetamine, and EFFEXOR XR. In addition, serial blood pressure and pulse measures will be obtained and examined to ensure that there are no unexpected changes in vital signs following co administration of SPD489 and EFFEXOR XR that would impact the further study of this drug combination. The hypothesis is that a drug drug interaction could possibly exist.

Conditions: Healthy
Being tested: LDX + Venlafaxine XR, Venlafaxine XR + LDX

What participants receive

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

LDX + Venlafaxine XRDrug
Also called Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489; Venlafaxine hydrochloride extended-release, Effexor XR,
- Day 1-5 LDX 30mg
- Day 6-10 LDX 50mg
- Day 11-15 LDX 70mg
- Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily
- Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily
- Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily
- Day 31-34 Venlafaxine XR 150mg daily
- Day 35-38 Venlafaxine XR 75mg daily.
Venlafaxine XR + LDXDrug
Also called Venlafaxine hydrochloride extended-release, Effexor XR; Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489
- Day 1-5 Venlafaxine XR 75mg
- Day 6-10 Venlafaxine XR 150mg
- Day 11-15 Venlafaxine XR 225mg
- Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily
- Day 21-25 Venlafaxine XR and LDX 50mg daily
- Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily
- Day 31-34 Venlafaxine XR 150mg
- Day 35-38 Venlafaxine XR 75mg.

Study groups in NCT01235338
Study group	Role	What they receive
LDX (SPD489) + Venlafaxine XR (Effexor XR)	Experimental	Not described Receives: Drug: LDX + Venlafaxine XR
Venlafaxine XR + LDX	Experimental	Not described Receives: Drug: Venlafaxine XR + LDX

What is being measured

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

Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate
Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.
Measured: Day 15 and Day 30 (24 hour sampling)
Cmax of d-Amphetamine
d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.
Measured: Day 15 and Day 30 (24 hour sampling)
Cmax of Venlafaxine Hydrochloride
Venlafaxine Hydrochloride is the active ingredient of Effexor XR
Measured: Day 15 and Day 30 (24 hour sampling)
Cmax of o-Desmethylvenlafaxine
Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.
Measured: Day 15 and Day 30 (24 hour sampling)
Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Measured: Day 15 and Day 30 (24 hour sampling)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate
Measured: Day 15 and Day 30 (24 hour sampling)
AUC of d-Amphetamine
Measured: Day 15 and Day 30 (24 hour sampling)
AUC of Venlafaxine Hydrochloride
Measured: Day 15 and Day 30 (24 hour sampling)
AUC of o-Desmethylvenlafaxine
Measured: Day 15 and Day 30 (24 hour sampling)
AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Measured: Day 15 and Day 30 (24 hour sampling)
Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate
Measured: Day 15 and Day 30 (24 hour sampling)
Tmax of d-Amphetamine
Measured: Day 15 and Day 30 (24 hour sampling)
Tmax of Venlafaxine Hydrochloride
Measured: Day 15 and Day 30 (24 hour sampling)
Tmax of o-Desmethylvenlafaxine
Measured: Day 15 and Day 30 (24 hour sampling)
Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Measured: Day 15 and Day 30 (24 hour sampling)

Secondary outcomes (3)

Systolic Blood Pressure
Measured: Baseline and up to 39 days
Diastolic Blood Pressure
Measured: Baseline and up to 39 days
Pulse Rate
Measured: Baseline and up to 39 days

Timeline

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

28 Oct 201017 Jan 2011

First posted5 Nov 2010 (estimated)
Study start28 Oct 2010
Primary completion30 Dec 2010
Study completion17 Jan 2011

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01235338
Sponsor's protocol ID: SPD489-117
Status last verified: Jun 2021
First submitted: 2 Nov 2010
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ermer J, Haffey MB, Richards C, Lasseter K, Roesch B, Purkayastha J, Corcoran M, Harlin B, Martin P. An open-label investigation of the pharmacokinetic profiles of lisdexamfetamine dimesylate and venlafaxine extended-release, administered alone and in combination, in healthy adults. Clin Drug Investig. 2013 Apr;33(4):243-54. doi: 10.1007/s40261-013-0073-1.
PubMed 23512639

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?

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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, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of SPD489 and EFFEXOR XR, Administered Alone and in Combination in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01235338
Acronym / sponsor ID: SPD489-117
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 28 Oct 2010 (actual)
Primary completion: 30 Dec 2010 (actual)
Study completion: 17 Jan 2011 (actual)
First posted: 5 Nov 2010 (estimated)
Results: Posted 8 Dec 2011

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LDX (SPD489) + Venlafaxine XR (Effexor XR)	Experimental	Drug: LDX + Venlafaxine XR
Venlafaxine XR + LDX	Experimental	Drug: Venlafaxine XR + LDX

Who may qualify

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

Key inclusion criteria (10 listed)

Age 18-45 years
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
Satisfactory medical assessment
Ability to provide information on family history of hypertension.

Key exclusion criteria (19 listed)

Current or recurrent disease (e.g., cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions)
Current or relevant previous history of physical or psychiatric illness.
Significant illness.
History of significant anxiety, tension, or agitation as assessed by the Investigator.
History of or current diagnosis of glaucoma.

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
LDX + Venlafaxine XRAlso: Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489; Venlafaxine hydrochloride extended-release, Effexor XR,* Day 1-5 LDX 30mg * Day 6-10 LDX 50mg * Day 11-15 LDX 70mg * Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily * Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily * Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily * Day 31-34 Venlafaxine XR 150mg daily * Day 35-38 Venlafaxine XR 75mg daily.	Drug	LDX (SPD489) + Venlafaxine XR (Effexor XR)
Venlafaxine XR + LDXAlso: Venlafaxine hydrochloride extended-release, Effexor XR; Lisdexamfetamine dimesylate, LDX, Vyvanse, SPD489* Day 1-5 Venlafaxine XR 75mg * Day 6-10 Venlafaxine XR 150mg * Day 11-15 Venlafaxine XR 225mg * Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily * Day 21-25 Venlafaxine XR and LDX 50mg daily * Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily * Day 31-34 Venlafaxine XR 150mg * Day 35-38 Venlafaxine XR 75mg.	Drug	Venlafaxine XR + LDX

Primary outcome

Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate
Time frame: Day 15 and Day 30 (24 hour sampling)
Lisdexamfetamine dimesylate (SPD489) itself is inactive, but following oral administration is converted to the active isomer, d-amphetamine, that is responsible for the drug's therapeutic activity.
Cmax of d-Amphetamine
Time frame: Day 15 and Day 30 (24 hour sampling)
d-Amphetamine is the active isomer of Lisdexamfetamine dimesylate (SPD489) and is responsible for the drug's therapeutic activity.
Cmax of Venlafaxine Hydrochloride
Time frame: Day 15 and Day 30 (24 hour sampling)
Venlafaxine Hydrochloride is the active ingredient of Effexor XR
Cmax of o-Desmethylvenlafaxine
Time frame: Day 15 and Day 30 (24 hour sampling)
Venlafaxine, after oral administration, is metabolized in the liver to an active metabolite, o-Desmethylvenlafaxine.
Cmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Time frame: Day 15 and Day 30 (24 hour sampling)
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of d-Amphetamine
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of Venlafaxine Hydrochloride
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of o-Desmethylvenlafaxine
Time frame: Day 15 and Day 30 (24 hour sampling)
AUC of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Time frame: Day 15 and Day 30 (24 hour sampling)
Time of Maximum Plasma Concentration (Tmax) of Lisdexamfetamine Dimesylate
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of d-Amphetamine
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of Venlafaxine Hydrochloride
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of o-Desmethylvenlafaxine
Time frame: Day 15 and Day 30 (24 hour sampling)
Tmax of Composite (Venlafaxine + o-Desmethylvenlafaxine)
Time frame: Day 15 and Day 30 (24 hour sampling)

3 secondary outcomes

Systolic Blood Pressure
Time frame: Baseline and up to 39 days
Diastolic Blood Pressure
Time frame: Baseline and up to 39 days
Pulse Rate
Time frame: Baseline and up to 39 days

Results and safety

Results posted to the registry on 8 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LDX + Venlafaxine XR	42	31
Venlafaxine XR + LDX	38	33

Primary outcome: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate

Time frame: Day 15 and Day 30 (24 hour sampling). Mean (Standard Deviation). Unit: ng/ml

Measure	LDX + Venlafaxine XR n = 32	Venlafaxine XR + LDX n = 34
Day 15	49.06 (32.25)	0 (0)
Day 30	49.84 (34.3)	50.77 (19.68)

Population analysed: Pharmacokinetic Analysis Set (PAS) defined as all subjects who took a t least 1 dose of investigational product and had at least 1 post-dose safety assessment and who had no major deviations related to investigational product intake (e.g. vomiting) and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Primary outcome: Cmax of d-Amphetamine

Time frame: Day 15 and Day 30 (24 hour sampling). Mean (Standard Deviation). Unit: ng/ml

Measure	LDX + Venlafaxine XR n = 32	Venlafaxine XR + LDX n = 34
Day 15	88.91 (26.87)	0 (0)
Day 30	88.91 (22.72)	85.27 (20.55)

Population analysed: PAS

Primary outcome: Cmax of Venlafaxine Hydrochloride

Time frame: Day 15 and Day 30 (24 hour sampling). Mean (Standard Deviation). Unit: ng/ml

Measure	LDX + Venlafaxine XR n = 32	Venlafaxine XR + LDX n = 34
Day 15	0 (0)	210.98 (120.6)
Day 30	198.5 (105.48)	228.89 (124.42)

Population analysed: PAS

Primary outcome: Cmax of o-Desmethylvenlafaxine

Time frame: Day 15 and Day 30 (24 hour sampling). Mean (Standard Deviation). Unit: ng/ml

Measure	LDX + Venlafaxine XR n = 32	Venlafaxine XR + LDX n = 34
Day 15	0 (0)	420.55 (139.67)
Day 30	413.71 (149.97)	371.54 (104.92)

Population analysed: PAS

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LDX (SPD489)	1 of 40 (2.5%)	33 of 40 (82.5%)	Not reported
LDX + Venlafaxine XR/Venlafaxine XR + LDX	0 of 67 (0%)	46 of 67 (68.7%)	Not reported
Venlafaxine XR Titration	0 of 37 (0%)	25 of 37 (67.6%)	Not reported
Venlafaxine XR Tapering	0 of 67 (0%)	20 of 67 (29.9%)	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 23512639Ermer J, Haffey MB, Richards C, Lasseter K, Roesch B, Purkayastha J, Corcoran M, Harlin B, Martin P. An open-label investigation of the pharmacokinetic profiles of lisdexamfetamine dimesylate and venlafaxine extended-release, administered alone and in combination, in healthy adults. Clin Drug Investig. 2013 Apr;33(4):243-54. doi: 10.1007/s40261-013-0073-1.
FDA Recall InformationLink 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 LDX + Venlafaxine XR and Venlafaxine XR + LDX 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 10 inclusion and 19 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 8 Dec 2011). 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 Lisdexamfetamine Dimesylate (time frame: Day 15 and Day 30 (24 hour sampling)). The study lists 15 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 NCT01235338, 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.