Phase 1
Completed N=16
Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT00893971 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Symptoms of Dry Mouth — 3; 1; 3; 1 Participants
Summary
The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms of Dry Mouth |
3; 1; 3; 1; 4; 3 | — |
| PRIMARY Symptoms of Tremor |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Blood Chemistry Change From Baseline |
2.99; 3.59; 1.39; 2; 0.07; -1.21 | — |
| PRIMARY Hematology Change From Baseline |
2.45; 2.95; 1.73; 3.33 | — |
| PRIMARY Heart Rate Change From Baseline |
2.0; 4.4; 2.9; 1.8 | — |
| PRIMARY Vital Sign Change Baseline; Blood Pressure |
3.3; 1.0; 0.1; 0.4; 6.3; 1.5 | — |
| PRIMARY Vital Sign Change From Baseline, SpO2 |
0.2; 0.1; -0.1; 0.1 | — |
| PRIMARY ECG Change From Baseline |
-11.0; -8.3; -5.3; -10.4; -3.0; -5.4 | — |
| PRIMARY Spirometry Change From Baseline |
40.4; 32.1; 40.1; 31.6 | — |
| PRIMARY Serum Potassium Change From Baseline |
4.4; 4.1; 4.1; 4.2 | — |
| SECONDARY Plasma Glycopyrrolate PK Parameters |
156.6; 100.1; 78.4; 156.7; 100.6; 80.1 | — |
| SECONDARY Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL) |
172.4; 137.2; 100.8 | — |
| SECONDARY Plasma Glycopyrrolate PK Parameters (Tmax) |
0.16; 0.07; 0.06 | — |
| SECONDARY Plasma Glycopyrrolate PK Parameters (t1/2) |
5.34; 5.12; 5.12 | — |
| SECONDARY Plasma Glycopyrrolate PK Parameters Cmax (pg/mL) |
61.3; 77.8; 44.4 | — |
| SECONDARY Plasma Glycopyrrolate PK Parameters (ke) |
0.143; 0.147; 0.155 | — |
| SECONDARY Plasma Formoterol PK Parameters |
47.9; 61.2; 57.9; 48.1; 61.2; 57.8 | — |
| SECONDARY Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL) |
56.1; 76.4; 67.0 | — |
| SECONDARY Plasma Formoterol PK Parameters (Tmax) |
0.28; 0.27; 0.43 | — |
| SECONDARY Plasma Formoterol PK Parameters (t1/2) |
5.12; 5.28; 5.8 | — |
| SECONDARY Plasma Formoterol PK Parameters (Cmax) |
10.4; 13.2; 11.9 | — |
| SECONDARY Plasma Formoterol PK Parameters (ke) |
0.142; 0.135; 0.126 | — |
Eligibility Criteria
Inclusion Criteria
- Provide signed written informed consent
- 18-55 years of age
- Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
- Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
- Body mass index (BMI) between 18.5 and 30, inclusive
- Non-smokers for at least 6 months prior to screening
- Pulmonary function tests within normal limits
- Willing to remain at the study center for at least 12-24 hours on each test day
- Venous access in both arms to allow collection of numerous blood samples
Exclusion Criteria
- Women who are pregnant or lactating
- Clinically significant medical conditions
- Viral illness within the last 30 days
- Symptomatic prostatic hypertrophy or bladder neck obstruction
- Known narrow-angle glaucoma
- History of bowel obstruction
- Clinically significant abnormal electrocardiogram
- Positive Hepatitis B surface antigen or positive Hepatitis C antibody
- Positive screening test for HIV antibodies
- History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
- Known or suspected history of alcohol or drug abuse within the last 2-years
- Greater than normal alcohol consumption
- Ingestion of any poppy seeds within the 48 hours prior to the screening
- Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
- Positive breath alcohol result
- Positive urine drug screen
- Use of any beta2-agonists, or anticholinergics prior to the recruitment interview
- Lower respiratory tract infections requiring antibiotics in the previous 6 weeks
- Use of any other prescription medication
- Use of any over the counter product, herbal product, diet aid, hormone supplement
- Donation > 450 ml of blood within 8 weeks of first treatment dose
- Clinically significant vital sign abnormality
- Clinically significant biochemical, hematological or urinalysis abnormality
- Affiliations with investigator site
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives prior to screening, whichever is longer
Data sourced from ClinicalTrials.gov (NCT00893971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.