Back to results

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

MK-1029

Placebo for MK-1029

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

If female, must be of non-childbearing potential
Have a history of mild to moderate asthma for at least 6 months
Other than asthma, in general good health
Able to perform reproducible pulmonary function testing
Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months
Have body mass index (BMI) ≥17 kg/m^2, but ≤35 kg/m^2

Exclusion Criteria:

Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of >20% from the Screening Visit to the Baseline Visit
Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit
Require the use of >8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or >2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit
Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists [SABA]) at any time from the Screening Visit up to the Baseline Visit
Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma
Require the chronic use of high-dose inhaled corticosteroids
Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma
Have a history of any illness that might confound the results of the study or poses additional risk to the participant
Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection
Is nursing
Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

Sites / Locations

Call for Information
Call for Information
Merck Sharp & Dohme
Merck Sharp & Dohme (New Zealand) Ltd.,
MSD (Pty) LTD South Africa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MK-1029

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Who Experienced One or More Adverse Events

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Number of Participants Who Discontinued Study Treatment Due to An Adverse Event

An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Secondary Outcome Measures

Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029

Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.

Maximum Plasma Concentration (Cmax) of MK-1029

Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.

Time to Maximum Plasma Concentration (Tmax) of MK-1029

Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026.

Full Information

NCT ID

NCT01370317

First Posted

June 8, 2011

Last Updated

August 22, 2018

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01370317

Brief Title

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

Official Title

Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2011 (Actual)

Primary Completion Date

December 27, 2011 (Actual)

Study Completion Date

December 27, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK-1029

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MK-1029

Intervention Description

Five (5) X 100 mg capsules, orally, once daily for 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo for MK-1029

Intervention Description

Five (5) X 100 mg capsules, orally, once daily for 28 days

Primary Outcome Measure Information:

Title

Number of Participants Who Experienced One or More Adverse Events

Description

Time Frame

Up to 42 days after initial dose of study treatment

Title

Number of Participants Who Discontinued Study Treatment Due to An Adverse Event

Description

Time Frame

Up to 28 days after initial dose of study treatment

Secondary Outcome Measure Information:

Title

Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029

Description

Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.

Time Frame

Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

Title

Maximum Plasma Concentration (Cmax) of MK-1029

Description

Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.

Time Frame

Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

Title

Time to Maximum Plasma Concentration (Tmax) of MK-1029

Description

Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026.

Time Frame

Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: If female, must be of non-childbearing potential Have a history of mild to moderate asthma for at least 6 months Other than asthma, in general good health Able to perform reproducible pulmonary function testing Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months Have body mass index (BMI) ≥17 kg/m^2, but ≤35 kg/m^2 Exclusion Criteria: Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of >20% from the Screening Visit to the Baseline Visit Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit Require the use of >8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or >2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists [SABA]) at any time from the Screening Visit up to the Baseline Visit Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma Require the chronic use of high-dose inhaled corticosteroids Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma Have a history of any illness that might confound the results of the study or poses additional risk to the participant Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection Is nursing Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

Call for Information

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Call for Information

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

Merck Sharp & Dohme

City

North Ryde

Country

Australia

Facility Name

Merck Sharp & Dohme (New Zealand) Ltd.,

City

Wellington

Country

New Zealand

Facility Name

MSD (Pty) LTD South Africa

City

Midrand

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

We'll reach out to this number within 24 hrs