Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
Information source: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: A006 DPI (Drug); A006 DPI (Drug); Proventil® MDI (Drug); Proventil® MDI (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Amphastar Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Study Director, Study Director, Affiliation: Amphastar Pharmeceuticals, Inc.
Summary
The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of
A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220
mcg (T2), in healthy male and female adult volunteers.
Clinical Details
Official title: Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers (A Randomized, Double- or Evaluator-blinded, Single-dose, Four-arm, Crossover Pharmacokinetics (PK) Study in Healthy Adults)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Area Under the Curve of Drug Concentration versus Time (AUC[0-t])Peak Plasma Concentration (C[max]) Time to Reach Peak Plasma Concentration (t[max]) Plasma Albuterol Concentrations at All Time Points
Detailed description:
This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK
study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of
age.
All candidates will be screened and only those who satisfy all enrollment criteria will be
enrolled into this study. Each study subject will participate in a screening visit and four
(4) study visits with one (1) randomized study treatment given in each visit.
PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS)
safety evaluation will be conducted at the end of Study Visit-4.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Generally healthy, male and female adults, 18-40 years of age at Screening;
- Having no clinically significant respiratory, cardiovascular and other systemic or
organic illnesses;
- Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18. 5 -
30. 0 kg/m2 inclusive;
- Sitting blood pressure ≤ 135/90 mmHg;
- Demonstrating negative HIV, HBsAg and HCV tests, alcohol and nine panel urine drug
screen tests;
- Demonstrating proficiency in the use of DPI and MDI or able to be trained in the
proper use of these devices;
- Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training),
for at least 2 times consecutively, with a maximum of 5 attempts;
- Having no known hypersensitivity to any ingredients of A006 and Proventil® MDI
(Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, or ethanol).
(Subjects must be able to tolerate at least one teaspoon of milk);
- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing
a clinically acceptable form of birth control; and
- Having properly consented and satisfied all other inclusion/exclusion criteria as
required for this protocol.
Exclusion Criteria:
- A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to
Screening;
- Upper respiratory tract infections within 2 weeks, or lower respiratory tract
infection within 4 weeks, prior to Screening;
- Previous history of asthma or COPD;
- Any current or recent respiratory conditions that, per investigator discretion, might
significantly affect pharmacodynamic response to the study drugs, including cystic
fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory
diseases;
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic,
hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of
the investigator could impact on the conduct, safety and evaluation of the study;
- ECG at Screening and Visit-1 baseline expressed any single or multiple premature
ventricular contractions (PVC);
- ECG at Screening and Visit-1 baseline with a QTc reading greater than 450ms;
- Use of prohibited drugs or failure to observe the drug washout restrictions; and
- Having been on other clinical drug/device studies or donated blood in the last 30
days prior to Screening.
Locations and Contacts
WCCT Global, LLC, Cypress, California 90630, United States
Additional Information
Related publications: Lipworth BJ, Clark DJ. Lung delivery of salbutamol given by breath activated pressurized aerosol and dry powder inhaler devices. Pulm Pharmacol Ther. 1997 Aug;10(4):211-4. Ahrens RC. The role of the MDI and DPI in pediatric patients: "Children are not just miniature adults". Respir Care. 2005 Oct;50(10):1323-8; discussion 1328-30. Review. Goldstein DA, Tan YK, Soldin SJ. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol. 1987;32(6):631-4. Hindle M, Newton DA, Chrystyn H. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Chest. 1995 Mar;107(3):629-33.
Starting date: August 2014
Last updated: April 6, 2015
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