Trial Outcomes & Findings for Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers (NCT NCT01786876)

NCT ID: NCT01786876

Last Updated: 2021-06-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: Over 240 hours post-dose
• Results posted on: 2021-06-10

Participant Flow

Participant milestones

Measure	Radiolabelled SSP-002358 A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Radiolabelled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.5 Years STANDARD_DEVIATION 2.07 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment UNITED STATES	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358	43476 pg*h/ml Standard Deviation 13801

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358	4643 pg/ml Standard Deviation 894

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358	1.25 hours Full Range 1.17 • Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=5 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358	11.0 hours Standard Deviation 2.38

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358	101960 pg equivalents*h/ml Standard Deviation 41581

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358	9252 pg equivalents/ml Standard Deviation 2138

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358	2.00 hours Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358	6.96 hours Standard Deviation 1.51

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358	137314 pg equivalents*h/ml Standard Deviation 56101

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358	11658 pg equivalents/ml Standard Deviation 3538

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358	1.50 hours Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358	10.9 hours Standard Deviation 2.54

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358	38.2 percentage of radioactivity Standard Deviation 10.3

PRIMARY outcome

Timeframe: Over 240 hours post-dose

Population: 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.

Outcome measures

Measure	Radiolabeled SSP-002358 n=6 Participants A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358	57.3 percentage of radioactivity Standard Deviation 10.4

Adverse Events

Radiolabelled SSP-002358

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Radiolabelled SSP-002358 n=6 participants at risk A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
Gastrointestinal disorders Diarrhoea	83.3% 5/6 • Number of events 7
Injury, poisoning and procedural complications Scratch	16.7% 1/6 • Number of events 1

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

• Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
• Publication restrictions are in place

Restriction type: OTHER