Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Midazolam; Drug: SSP-004184SS

• Registration Number: NCT01989169
• Lead Sponsor: Shire

Brief Summary

A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-20
• Study Start: 2013-11-26
• Primary Completion: 2014-01-06
• Study Completion: 2014-01-06
• Results First Submitted: 2014-12-16
• Results First Submitted QC: 2014-12-16
• Results First Posted: 2014-12-24
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Normal healthy male and female volunteers between the ages of 18 and 65, inclusive
• Serum ferritin, hemoglobin and erythrocyte indices within normal range

Exclusion Criteria

• Evidence of any active or chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SSP-004184SS + Midazolam	SSP-004184SS	Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
Midazolam	Midazolam	Administered as a single oral 6 mg dose on Day 1.
SSP-004184SS + Midazolam	Midazolam	Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of Midazolam	Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.	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.
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam	Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.	AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero 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 Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam	Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.	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.

Trial Locations

Locations (1)

Clinical Pharmacology of Miami, Inc.; 🇺🇸 Miami, Florida, United States