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

NCT ID: NCT01989169

Last Updated: 2021-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-26

Study Completion Date

2014-01-06

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Midazolam

Administered as a single oral 6 mg dose on Day 1.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

SSP-004184SS + Midazolam

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

SSP-004184SS

Intervention Type DRUG

Interventions

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Midazolam

Intervention Type DRUG

SSP-004184SS

Intervention Type DRUG

Other Intervention Names

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SPD602

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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SPD602-117

Identifier Type: -

Identifier Source: org_study_id

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