---
title: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
nct_id: NCT01370317
overall_status: COMPLETED
phase: PHASE1
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Asthma
countries: United States, Australia, New Zealand, South Africa
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01370317.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01370317"
ct_last_update_post_date: 2019-01-25
last_seen_at: "2026-05-12T06:49:52.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01370317](https://clinicaltrials.gov/study/NCT01370317)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 27
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Asthma
- **Start Date:** 2011-06-01
- **Completion Date:** 2011-12-27
- **CT.gov Last Update:** 2019-01-25

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **MK-1029** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **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

- **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.
- **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

- **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)_
- **Maximum Plasma Concentration (Cmax) of MK-1029** _(time frame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose)_
- **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)_

## Locations (5)

- Call for Information, Costa Mesa, California, United States
- Call for Information, Rolling Hills Estates, California, United States
- Merck Sharp & Dohme, North Ryde, Australia
- Merck Sharp & Dohme (New Zealand) Ltd.,, Wellington, New Zealand
- MSD (Pty) LTD South Africa, Midrand, South Africa

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.call for information|costa mesa|california|united states` — added _(2026-05-12)_
- `locations.call for information|rolling hills estates|california|united states` — added _(2026-05-12)_
- `locations.merck sharp & dohme|north ryde||australia` — added _(2026-05-12)_
- `locations.merck sharp & dohme (new zealand) ltd.,|wellington||new zealand` — added _(2026-05-12)_
- `locations.msd (pty) ltd south africa|midrand||south africa` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01370317*  
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