Healthy VolunteersPhase 1NCT01786876

Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers

A Phase 1 study testing Radiolabeled SPD557 in people with Healthy Volunteers, 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.

Trial summary

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its… Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Radiolabeled SPD557
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 7 Mar 2013to 12 Apr 2013
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Males ages 18 to 50 years
Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2
Subject is willing to comply with any applicable contraceptive and sperm donation requirements

Who cannot join

Have participated in a [14C]-study within the last 6 months.
Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects

Conditions: Healthy Volunteers
Being tested: Radiolabeled SPD557
Keywords: Radiolabelled, AME

What participants receive

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

Radiolabeled SPD557Drug
A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Study groups in NCT01786876
Study group	Role	What they receive
Radiolabeled SPD557	Experimental	Not described Receives: Drug: Radiolabeled SPD557

What is being measured

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

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358
Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Measured: Over 240 hours post-dose
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Measured: Over 240 hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358
Measured: Over 240 hours post-dose

Timeline

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

7 Mar 201312 Apr 2013

First posted8 Feb 2013 (estimated)
Study start7 Mar 2013
Primary completion12 Apr 2013
Study completion12 Apr 2013

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 Healthy VolunteersStudies 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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01786876
Sponsor's protocol ID: SPD557-107
Status last verified: May 2021
First submitted: 6 Feb 2013
Last updated: 10 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Flach S, Croft M, Ding J, Budhram R, Pankratz T, Pennick M, Scarfe G, Troy S, Getsy J. Pharmacokinetics, absorption, and excretion of radiolabeled revexepride: a Phase I clinical trial using a microtracer and accelerator mass spectrometry-based approach. Drug Des Devel Ther. 2016 Sep 27;10:3125-3132. doi: 10.2147/DDDT.S107843. eCollection 2016.
PubMed 27729771

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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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01786876
Acronym / sponsor ID: SPD557-107
Conditions: Healthy Volunteers
Keywords: Radiolabelled, AME
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 7 Mar 2013 (actual)
Primary completion: 12 Apr 2013 (actual)
Study completion: 12 Apr 2013 (actual)
First posted: 8 Feb 2013 (estimated)
Results: Posted 27 Mar 2014

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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Radiolabeled SPD557	Experimental	Drug: Radiolabeled SPD557

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Males ages 18 to 50 years
Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2
Subject is willing to comply with any applicable contraceptive and sperm donation requirements

Key exclusion criteria (4 listed)

Have participated in a [14C]-study within the last 6 months.
Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring).
Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days

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
Radiolabeled SPD557A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1	Drug	Radiolabeled SPD557

Primary outcome

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358
Time frame: Over 240 hours post-dose

Results and safety

Results posted to the registry on 27 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiolabelled SSP-002358	6	6

Primary outcome: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358

Time frame: Over 240 hours post-dose. Mean (Standard Deviation). Unit: pg*h/ml

Measure	Radiolabeled SSP-002358 n = 6
Value	43476 (13801)

Population analysed: Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.

Primary outcome: Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358

Time frame: Over 240 hours post-dose. Mean (Standard Deviation). Unit: pg/ml

Measure	Radiolabeled SSP-002358 n = 6
Value	4643 (894)

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358

Time frame: Over 240 hours post-dose. Median (Full Range). Unit: hours

Measure	Radiolabeled SSP-002358 n = 6
Value	1.25 (1.17)

Primary outcome: Plasma Half-Life (T1/2) of Radiolabelled SSP-002358

Time frame: Over 240 hours post-dose. Mean (Standard Deviation). Unit: hours

Measure	Radiolabeled SSP-002358 n = 5
Value	11.0 (2.38)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiolabelled SSP-002358	0 of 6 (0%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27729771Flach S, Croft M, Ding J, Budhram R, Pankratz T, Pennick M, Scarfe G, Troy S, Getsy J. Pharmacokinetics, absorption, and excretion of radiolabeled revexepride: a Phase I clinical trial using a microtracer and accelerator mass spectrometry-based approach. Drug Des Devel Ther. 2016 Sep 27;10:3125-3132. doi: 10.2147/DDDT.S107843. eCollection 2016.

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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 Radiolabeled SPD557 in people with Healthy Volunteers, 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 3 inclusion and 4 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 10 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 27 Mar 2014). 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?

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358 (time frame: Over 240 hours post-dose). The study lists 14 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 NCT01786876, 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 10 Jun 2021.