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Completed

NCT Number: NCT01370317

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merck Sharp & Dohme, North Ryde, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1029

Drug

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

Placebo for MK-1029

Drug

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

Primary outcomes

  1. Number of Participants Who Experienced One or More Adverse Events

    Time frame: Up to 42 days after initial dose of study treatment

    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.

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

    Time frame: Up to 28 days after initial dose of study treatment

    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 outcomes

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

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

    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.

  2. Maximum Plasma Concentration (Cmax) of MK-1029

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2011
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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