---
title: PK Study of PT003 and PT001 in Japanese Healthy Subjects
nct_id: NCT02196714
overall_status: COMPLETED
phase: PHASE1
sponsor: Pearl Therapeutics, Inc.
study_type: INTERVENTIONAL
primary_condition: COPD
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02196714.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02196714"
ct_last_update_post_date: 2017-04-26
last_seen_at: "2026-05-12T06:40:01.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# PK Study of PT003 and PT001 in Japanese Healthy Subjects

**Official Title:** A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects

**NCT ID:** [NCT02196714](https://clinicaltrials.gov/study/NCT02196714)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Pearl Therapeutics, Inc.
- **Conditions:** COPD
- **Start Date:** 2014-07
- **CT.gov Last Update:** 2017-04-26

## Brief Summary

A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

Informed Consent Form (ICF) prior to any study related procedures

* Male and female first generation Japanese subjects 18 to 45 years, inclusive
* Good general health
* Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
* Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion Criteria:

* Pregnancy, nursing female subjects, or subjects trying to conceive
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
* History of ECG abnormalities
* Cancer not in complete remission for at least 5 years
* Clinically significant, symptomatic prostatic hypertrophy
* Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
* Clinically significant bladder neck obstruction or urinary retention
* Inadequately treated glaucoma
* History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
* Subjects with pre-existing anemia and/or iron deficiency
```

## Arms

- **Glycopyrronium and Formoterol Fumarate (GFF) Dose 1** (EXPERIMENTAL) — Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
- **Glycopyrronium and Formoterol Fumarate (GFF) Dose 2** (EXPERIMENTAL) — Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
- **Glycopyrronium (GP) Dose 1** (EXPERIMENTAL) — Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
- **Glycopyrronium (GP) Dose 2** (EXPERIMENTAL) — Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

## Interventions

- **Glycopyrronium and Formoterol Fumarate (GFF) Dose 1** (DRUG) — Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
- **Glycopyrronium and Formoterol Fumarate (GFF) Dose 2** (DRUG) — Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
- **Glycopyrronium (GP) Dose 1** (DRUG) — Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
- **Glycopyrronium (GP) Dose 2** (DRUG) — Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

## Primary Outcomes

- **Cmax** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
- **Cmax** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
- **AUC 0-12** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)
- **AUC 0-12** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
- **AUC 0-t** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)
- **AUC 0-t** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
- **AUC 0-∞** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)
- **AUC 0-∞** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
- **Tmax** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)
- **Tmax** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
- **T 1/2** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)
- **T 1/2** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
- **CL/F** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
- **CL/F** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
- **Vd/F** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment
- **Vd/F** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
- **Lambda z** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
- **Lambda z** _(time frame: Day 1)_ — Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

## Secondary Outcomes

- **Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 Hours)_
- **Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 Hours)_
- **Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 Hours)_
- **Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 Hours)_
- **Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 hours)_
- **Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 hours)_
- **Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 hours)_
- **Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose** _(time frame: 12 hours)_
- **Change in Heart Rate From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_
- **Change in PR Interval From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_
- **Change in QRS Axis From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_
- **Change in QRS Duration From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_
- **Change in QT Interval From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_
- **Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_
- **Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose** _(time frame: 12 hours)_

## Locations (1)

- SNBL, Baltimore, Maryland, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — 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.snbl|baltimore|maryland|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02196714.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02196714*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*