HealthyPhase 1NCT01905540

A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)

A Phase 1 study testing SSP-004184AQ and SSP-004184SS 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.

Trial summary

This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SSP-004184AQ and SSP-004184SS
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 5 Aug 2013to 20 Sep 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18-65 years
Must be considered "healthy".
Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Who cannot join

Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.
Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
History of alcohol or other substance abuse within the last year.
A positive screen for alcohol or drugs of abuse at the Screening Visit.

Show all 12Show fewer

Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or <49mmHg.
Twelve-lead ECG demonstrating QTc >450msec at screening.
Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
A positive HIV antibody screen, HBsAg, or HCV antibody screen.
Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.

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, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of SSP-004184AQ (Magnesium Salt) to SSP-004184SS (Disodium Salt) Each Administered as a Single Dose and as Two Doses of SSP-004184 (Free Acid) in Healthy Adult Subjects

This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Conditions: Healthy
Being tested: SSP-004184AQ, SSP-004184SS

What participants receive

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

SSP-004184AQDrug
Also called SPD602
Magnesium salt
SSP-004184SSDrug
Also called SPD602
Disodium salt

Study groups in NCT01905540
Study group	Role	What they receive
SSP-004184AQ (single dose)	Experimental	40 mg/kg (oral capsule form) given once on Day 1 Receives: Drug: SSP-004184AQ
SSP-004184SS (single dose)	Experimental	21.8 mg/kg (oral capsule form) given once on Day 1 Receives: Drug: SSP-004184SS
SSP-004184AQ (2 doses)	Experimental	40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1 Receives: Drug: SSP-004184AQ
SSP-004184SS (2 doses)	Experimental	21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1 Receives: Drug: SSP-004184SS

What is being measured

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

Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose
AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. 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: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose
AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. 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: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Maximum Plasma Concentration (Cmax) of SSP-004184 After One 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 administrated
Measured: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Secondary outcomes (3)

Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses
AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. 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: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses
AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. 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: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Measured: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Timeline

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

5 Aug 201320 Sep 2013

First posted23 Jul 2013 (estimated)
Study start5 Aug 2013
Primary completion20 Sep 2013
Study completion20 Sep 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.
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: Crossover
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01905540
Sponsor's protocol ID: SPD602-111
Status last verified: Jun 2021
First submitted: 18 Jul 2013
Last updated: 19 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of SSP-004184AQ (Magnesium Salt) to SSP-004184SS (Disodium Salt) Each Administered as a Single Dose and as Two Doses of SSP-004184 (Free Acid) in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01905540
Acronym / sponsor ID: SPD602-111
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 5 Aug 2013 (actual)
Primary completion: 20 Sep 2013 (actual)
Study completion: 20 Sep 2013 (actual)
First posted: 23 Jul 2013 (estimated)
Results: Posted 24 Dec 2014

Clinical summary

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

This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
SSP-004184AQ (single dose)	Experimental	Drug: SSP-004184AQ40 mg/kg (oral capsule form) given once on Day 1
SSP-004184SS (single dose)	Experimental	Drug: SSP-004184SS21.8 mg/kg (oral capsule form) given once on Day 1
SSP-004184AQ (2 doses)	Experimental	Drug: SSP-004184AQ40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1
SSP-004184SS (2 doses)	Experimental	Drug: SSP-004184SS21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18-65 years
Must be considered "healthy".
Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Key exclusion criteria (12 listed)

Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs
Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.
Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.
Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months
History of alcohol or other substance abuse within the last year.

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
SSP-004184AQAlso: SPD602Magnesium salt	Drug	SSP-004184AQ (2 doses), SSP-004184AQ (single dose)
SSP-004184SSAlso: SPD602Disodium salt	Drug	SSP-004184SS (2 doses), SSP-004184SS (single dose)

Primary outcome

Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose
Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. 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
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose
Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. 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 SSP-004184 After One Dose
Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated

3 secondary outcomes

Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses
Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses
Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.
Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses
Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Results and safety

Results posted to the registry on 24 Dec 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
AQ-SS-AQ2	7	7
AQ-SS-SS2	7	7
SS-AQ-AQ2	7	7
SS-AQ-SS2	7	7

Primary outcome: Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose

Time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	SSP-004184AQ (Single Dose) n = 28	SSP-004184SS (Single Dose) n = 28
Value	261901.9 (71252.3)	164340 (43914)

SSP-004184AQ (Single Dose) vs SSP-004184SS (Single Dose): Ratio of geometric LS means: 1.244 (90% CI 1.081 to 1.430)

Population analysed: Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Primary outcome: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose

Measure	SSP-004184AQ (Single Dose) n = 26	SSP-004184SS (Single Dose) n = 28
Value	263911.3 (68979.4)	164614.8 (43858.8)

SSP-004184AQ (Single Dose) vs SSP-004184SS (Single Dose): Geometric LS Means: 1.233 (90% CI 1.070 to 1.422)

Primary outcome: Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose

Measure	SSP-004184AQ (Single Dose) n = 28	SSP-004184SS (Single Dose) n = 28
Value	110114.3 (26503)	77068.6 (21198.9)

SSP-004184AQ (Single Dose) vs SSP-004184SS (Single Dose): Ratio of geometric LS means: 1.344 (90% CI 1.135 to 1.592)

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
SSP-004184AQ (Single Dose)	0 of 28 (0%)	12 of 28 (42.9%)	Not reported
SSP-004184SS (Single Dose)	0 of 28 (0%)	11 of 28 (39.3%)	Not reported
SSP-004184AQ (2 Doses)	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
SSP-004184SS (2 Doses)	0 of 13 (0%)	5 of 13 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 SSP-004184AQ and SSP-004184SS 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 3 inclusion and 12 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 19 Jul 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 24 Dec 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 Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose (time frame: Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.). The study lists 3 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 NCT01905540.

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 19 Jul 2021.