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ADASUVE 2-dose Thorough QT/QTc Study

NCT ID: NCT01854710

Last Updated: 2017-10-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

Detailed Description

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It has been shown in a pre-marketing clinical study that clinically relevant QT prolongation does not appear to be associated with a single dose of ADASUVE. The potential risk of QTc prolongation following repeat dosing is unknown. Therefore the current study will assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

The study hypothesis H0: Placebo-subtracted max mean dQTc \> 10 msec

Conditions

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Healthy Volunteers

Keywords

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ADASUVE inhaled loxapine thorough QT/QTc study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-center, randomized, double-blind, double-dummy, 2-dose, 3-period, active- and placebo-controlled, crossover QT/QTc and pharmacokinetic (PK) study of ADASUVE in healthy volunteers. All dosing and treatment-day follow-up in the study was conducted in the clinical research unit (CRU)
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment sequence ABC

Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo

Group Type OTHER

ADASUVE 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled loxapine 10 mg 2 doses 2 hours apart

Inhaled Placebo

Intervention Type DRUG

Staccato placebo via inhalation x 2 at 2 hours apart

Oral moxifloxacin 400 mg

Intervention Type DRUG

Oral moxifloxacin 400 mg single dose

Oral placebo

Intervention Type DRUG

Oral capsule identical in appearance to moxifloxacin

Treatment sequence ACB

Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo

Group Type OTHER

ADASUVE 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled loxapine 10 mg 2 doses 2 hours apart

Inhaled Placebo

Intervention Type DRUG

Staccato placebo via inhalation x 2 at 2 hours apart

Oral moxifloxacin 400 mg

Intervention Type DRUG

Oral moxifloxacin 400 mg single dose

Oral placebo

Intervention Type DRUG

Oral capsule identical in appearance to moxifloxacin

Treatment sequence BCA

Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo

Group Type OTHER

ADASUVE 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled loxapine 10 mg 2 doses 2 hours apart

Inhaled Placebo

Intervention Type DRUG

Staccato placebo via inhalation x 2 at 2 hours apart

Oral moxifloxacin 400 mg

Intervention Type DRUG

Oral moxifloxacin 400 mg single dose

Oral placebo

Intervention Type DRUG

Oral capsule identical in appearance to moxifloxacin

Treatment sequence BAC

Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo

Group Type OTHER

ADASUVE 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled loxapine 10 mg 2 doses 2 hours apart

Inhaled Placebo

Intervention Type DRUG

Staccato placebo via inhalation x 2 at 2 hours apart

Oral moxifloxacin 400 mg

Intervention Type DRUG

Oral moxifloxacin 400 mg single dose

Oral placebo

Intervention Type DRUG

Oral capsule identical in appearance to moxifloxacin

Treatment sequence CAB

Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo

Group Type OTHER

ADASUVE 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled loxapine 10 mg 2 doses 2 hours apart

Inhaled Placebo

Intervention Type DRUG

Staccato placebo via inhalation x 2 at 2 hours apart

Oral moxifloxacin 400 mg

Intervention Type DRUG

Oral moxifloxacin 400 mg single dose

Oral placebo

Intervention Type DRUG

Oral capsule identical in appearance to moxifloxacin

Treatment sequence CBA

Treatment: A = Inhaled loxapine (2 doses of 10 mg 2 hours apart) + oral placebo, B = Inhaled placebo + oral placebo, C = Oral moxifloxacin 400 mg + Inhaled placebo

Group Type OTHER

ADASUVE 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled loxapine 10 mg 2 doses 2 hours apart

Inhaled Placebo

Intervention Type DRUG

Staccato placebo via inhalation x 2 at 2 hours apart

Oral moxifloxacin 400 mg

Intervention Type DRUG

Oral moxifloxacin 400 mg single dose

Oral placebo

Intervention Type DRUG

Oral capsule identical in appearance to moxifloxacin

Interventions

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ADASUVE 10 mg 2 doses 2 hours apart

Inhaled loxapine 10 mg 2 doses 2 hours apart

Intervention Type DRUG

Inhaled Placebo

Staccato placebo via inhalation x 2 at 2 hours apart

Intervention Type DRUG

Oral moxifloxacin 400 mg

Oral moxifloxacin 400 mg single dose

Intervention Type DRUG

Oral placebo

Oral capsule identical in appearance to moxifloxacin

Intervention Type DRUG

Other Intervention Names

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Staccato Loxapine AVELOX

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects between the ages of 18 to 65 years, inclusive.
* Body mass index (BMI) ≥18 and ≤32.
* Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 4-day period and 2 consecutive 3-day periods.
* Subjects who speak, read, and understand English and/or Dutch and are willing and able to provide written informed consent on an IEC approved form prior to the initiation of any study procedures.
* Subjects who are in good general health prior to study participation
* Female or male participants who agree to use a medically acceptable and effective birth control method

Exclusion Criteria

* Subjects who regularly consume large amounts of xanthine-containing substances (≥ 5 cups of coffee/day).
* Subjects who have taken prescription or nonprescription medication within 5 days of Visit 2.
* Subjects who have had an acute illness within the last 5 days of Visit 2.
* Subjects who have smoked tobacco within the last 30 days or who have a positive cotinine test.
* Subjects who have a history of HIV, anti-HCV or HbsAg positivity.
* Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-IV.
* Subjects who test positive for alcohol or have a positive urine drug screen.
* Subjects who have a history of allergy or intolerance to loxapine or amoxapine or history of bronchospasm following inhaled loxapine treatment.
* Subjects who have an ECG abnormality.
* Subjects who have hypotension, or hypertension.
* Subjects who have a history of unstable angina, syncope, coronary artery disease, myocardial infarction, congestive heart failure, transient ischemic attack, history of convulsions or other neurological disorder.
* Subjects who have a current history of asthma, chronic obstructive lung disease, or any other lung disease associated with bronchospasm.
* Subjects who use medications to treat airways disease, such as asthma or COPD.
* Subjects who have any acute respiratory signs/symptoms (e.g., wheezing).
* Female subjects who have a positive pregnancy test at screening or at admission to any of the treatment visits, or are breastfeeding.
* Subjects who have received an investigational drug within 60 days prior to the Screening Visit.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexza Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresa Nunes, MD

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

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PRA International

Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

References

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Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Nov;53(11):963-71. doi: 10.5414/CP202457.

Reference Type BACKGROUND
PMID: 26501204 (View on PubMed)

Cassella JV, Spyker DA, Yeung PP. A randomized, placebo-controlled repeat-dose thorough QT study of inhaled loxapine in healthy volunteers. Int J Clin Pharmacol Ther. 2015 Oct 7. doi: 10.5414/CP202457. Online ahead of print.

Reference Type DERIVED
PMID: 26445139 (View on PubMed)

Other Identifiers

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204-407

Identifier Type: OTHER

Identifier Source: secondary_id

AMDC-204-407

Identifier Type: -

Identifier Source: org_study_id