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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00800579




Registration number
NCT00800579
Ethics application status
Date submitted
21/11/2008
Date registered
2/12/2008
Date last updated
21/10/2009

Titles & IDs
Public title
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
Scientific title
A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
Secondary ID [1] 0 0
GS-US-221-0101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-9411
Treatment: Drugs - Placebo

Experimental: 1 - GS-9411 0.6 mg

Experimental: 2 - GS-9411 1.2 mg

Experimental: 3 - GS-9411 2.4 mg

Placebo comparator: 4 - Inhaled volume-matched sterile saline placebo


Treatment: Drugs: GS-9411
Inhaled GS-9411 dissolved in sterile saline

Treatment: Drugs: Placebo
Inhaled volume-matched placebo in sterile saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of 3 escalating doses of GS-9411 in healthy male volunteers
Timepoint [1] 0 0
11 Days
Secondary outcome [1] 0 0
To assess pharmacokinetics of GS-9411 and its metabolites
Timepoint [1] 0 0
11 Days

Eligibility
Key inclusion criteria
* Males 18 to 45 years of age.
* No clinically important abnormal physical findings at screening.
* No clinically relevant abnormal lab results at screening.
* Normal (or abnormal but not clinically significant) ECG.
* Normal (or abnormal but not clinically significant) blood pressure (BP) and heart rate (HR).
* Body weight between 70 and 125 kg and body mass index (BMI) between 18 and 28 kg/m2, or outside range, but not clinically significant and agreed with sponsor and principal investigator.
* Able to communicate well with the investigator and to comply with the requirements of the entire study.
* Provision of written informed consent.
* Non-smokers of at least 6 months duration (< 10 pack year history) prior to study entry.
* Negative for drugs of abuse (including alcohol) at Screening and Day -5.
* Must be willing to abstain from alcohol and strenuous exercise during the 48-hour period prior to admission and while confined to the clinic.
* Forced expiratory volume in 1 second (FEV1) greater than or equal to 80% of predicted normal for age, gender, and height as per Hankinson et al1 at Screening and Pre-dose.
* Normal intraocular pressure between 10 and 22 mmHg.
* Male subjects who are sexually active must be willing to use effective barrier contraception (e.g., condom) during heterosexual intercourse from Baseline/Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug.
* Male subjects must refrain from sperm donation from Day 1 through completion of the study and continuing for at least 30 days from the date of last dose of study drug.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Administration of any investigational drug in the period 0 to 12 weeks before entry to the study.
* A need for any medication during the period 0 to 5 days before entry to the study, except those deemed by the principal investigator/clinical investigator not to interfere with the outcome of the study.
* Existence of any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism, or excretion of the drug.
* Presence or history of allergy requiring treatment. Hay fever is allowed unless it is active or has required treatment within the previous 2 months.
* Donation or loss of greater than 400 mL of blood in the period 0 to 12 weeks before entry to the study.
* Serious adverse reaction or hypersensitivity to any drug.
* Presence or history of any pulmonary diseases (e.g., asthma, emphysema, chronic bronchitis, cystic fibrosis, bronchiectasis).
* Consumption of drugs and/or herbal preparations capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) or enzyme-inhibiting agents (e.g., cimetidine) or similar drugs within 30 days (or 5 half-lives of inducing/inhibiting agent, whichever is longer) of enrollment in this study.
* Major surgery within 6 months of the start of this study.
* Subjects who have experienced a significant upper or lower respiratory tract infection within the 6 weeks prior to admission.
* Subjects with significant history of respiratory, renal, hepatic, cardiovascular (including history of systemic hypertension requiring therapy), metabolic, neurological, hematological, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study or require treatment which may affect the evaluation of efficacy and safety of the study drug.
* Subjects with elevated liver enzyme concentrations.
* Haemoglobin level < 130 g/L taken at Screening and at Pre-dose.
* Plasma potassium > 5 mEq/L taken at Screening and at Pre-dose.
* Poor venous access.
* Intraocular pressure > 21 mm Hg

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.
Trial website
https://clinicaltrials.gov/study/NCT00800579
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Hodsman, MD
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00800579