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

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ClinicalTrials.gov Identifier: NCT01989169
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : December 24, 2014
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Midazolam Drug: SSP-004184SS Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
Actual Study Start Date : November 26, 2013
Actual Primary Completion Date : January 6, 2014
Actual Study Completion Date : January 6, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Midazolam
Administered as a single oral 6 mg dose on Day 1.
 Drug: Midazolam
Experimental: SSP-004184SS + Midazolam
Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
 Drug: Midazolam
Drug: SSP-004184SS
Other Name: SPD602


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam [ Time Frame: 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.

  2. Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam [ Time Frame: 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.

  3. Maximum Plasma Concentration (Cmax) of Midazolam [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989169


Locations
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United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01989169    
Other Study ID Numbers: SPD602-117
First Posted: November 20, 2013    Key Record Dates
Results First Posted: December 24, 2014
Last Update Posted: June 24, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action