Back to resultsSingle Ascending Dose Study of TRN-157 in Healthy Subjects
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TRN-157
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Subject has provided written informed consent
- The subject is male or female 18 to 65 years of age
- If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be
- Non-smoker
- Good general health
- Willing to abstain from alcohol, caffeine, and xanthine-containing beverages
- The subject is compliant and available throughout the entire study period
Exclusion Criteria:
Current diagnosis, as per subject or investigator or screening assessment, of:
- unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
- history of narrow angle glaucoma
- history of alcohol abuse within the past 5 years
- history of smoking within the past 6 months
- positive result for the alcohol and/or drugs of abuse
- weight > 100 kg or < 50 kg
- clinically significant abnormal ECG
- history of clinically significant (per the Investigator) disease or disorder
- any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
Abnormal vital signs defined as any of the following:
- Systolic blood pressure ≥ 140 mmHg
- Diastolic blood pressure ≥ 90mmHg
- Heart rate < 40 or > 85 beats per minute
- Fever or other clinically significant physical exam findings
- Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- History or current symptom(s) of respiratory tract inflammation
- Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
- Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
- FEV1 variability > 10% between study visits
- Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding
- Currently being treated for hypertension or taking any other medications that affect blood pressure significantly
- Inability to perform acceptable, quality serial spirometry or any other study procedures
- Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TRN-157
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability as determined by number of subjects with adverse events
Secondary Outcome Measures
Determination of pharmacokinetic parameters
Area Under the Plasma Concentration-Time Curve from Zero to the Time of the Last Measurable Concentration (AUC0-t)
Determination of pharmacokinetic parameters
Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-inf)
Determination of pharmacokinetic parameters
Peak Plasma Concentration (Cmax)
Determination of pharmacokinetic parameters
Time to Peak Plasma Concentration (tmax)
Determination of pharmacokinetic parameters
Half-Life (t½)
Determination of pharmacokinetic parameters
Elimination Rate Constant (kel)
Determination of pharmacokinetic parameters
Volume of Distribution at Steady State after Non-IV Administration (Vss/F)
Determination of pharmacokinetic parameters
Total Plasma Clearance after Non-IV Administration (CL/F)
Full Information
NCT ID
NCT02133339
First Posted
May 5, 2014
Last Updated
October 29, 2014
Sponsor
Theron Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02133339
Brief Title
Single Ascending Dose Study of TRN-157 in Healthy Subjects
Official Title
A Phase I, Randomized, Double-blind, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of Nebulized, TRN-157 Inhalation Solution in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theron Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
This single ascending dose study is to determine and evaluate the safety and tolerability of TRN-157 in approximately 40 healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRN-157
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TRN-157
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability as determined by number of subjects with adverse events
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Determination of pharmacokinetic parameters
Description
Area Under the Plasma Concentration-Time Curve from Zero to the Time of the Last Measurable Concentration (AUC0-t)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Area Under the Plasma Concentration-Time Curve from Zero to Infinity (AUC0-inf)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Peak Plasma Concentration (Cmax)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Time to Peak Plasma Concentration (tmax)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Half-Life (t½)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Elimination Rate Constant (kel)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Volume of Distribution at Steady State after Non-IV Administration (Vss/F)
Time Frame
1 week
Title
Determination of pharmacokinetic parameters
Description
Total Plasma Clearance after Non-IV Administration (CL/F)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject has provided written informed consent
The subject is male or female 18 to 65 years of age
If the subject or subject's partner is of childbearing potential, a medically acceptable form of contraception will be
Non-smoker
Good general health
Willing to abstain from alcohol, caffeine, and xanthine-containing beverages
The subject is compliant and available throughout the entire study period
Exclusion Criteria:
Current diagnosis, as per subject or investigator or screening assessment, of:
unstable or uncontrolled disease in any organ system (including cardiovascular) on present therapy
history of narrow angle glaucoma
history of alcohol abuse within the past 5 years
history of smoking within the past 6 months
positive result for the alcohol and/or drugs of abuse
weight > 100 kg or < 50 kg
clinically significant abnormal ECG
history of clinically significant (per the Investigator) disease or disorder
any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
Abnormal vital signs defined as any of the following:
Systolic blood pressure ≥ 140 mmHg
Diastolic blood pressure ≥ 90mmHg
Heart rate < 40 or > 85 beats per minute
Fever or other clinically significant physical exam findings
Current or history of clinically significant respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
History or current symptom(s) of respiratory tract inflammation
Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
Abnormal FEV1, FVC, or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
FEV1 variability > 10% between study visits
Female of childbearing potential with a positive serum pregnancy test or currently breastfeeding
Currently being treated for hypertension or taking any other medications that affect blood pressure significantly
Inability to perform acceptable, quality serial spirometry or any other study procedures
Positive screen for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV antibody
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Oren
Organizational Affiliation
Theron Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Cypress
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single Ascending Dose Study of TRN-157 in Healthy Subjects
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