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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00951522




Registration number
NCT00951522
Ethics application status
Date submitted
3/08/2009
Date registered
4/08/2009
Date last updated
25/09/2009

Titles & IDs
Public title
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
Scientific title
A Phase 1 Randomized, 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-221-0102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Mucociliary Clearance 0 0
Airway Hydration 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 2.4 mg

Experimental: 2 - GS-9411 4.8 mg

Experimental: 3 - GS-9411 7.2 mg

Experimental: 4 - GS-9411 9.6 mg

Placebo Comparator: 5 - Placebo


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

Treatment: Drugs: Placebo
Inhaled 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 4 escalating doses of GS-9411 in healthy male volunteers
Timepoint [1] 0 0
7 Days

Eligibility
Key inclusion criteria
- Males 18 to 45 years of age

- No clinically important abnormal physical findings at the screening examination

- No clinically relevant abnormalities in the results of laboratory screening evaluation

- 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.

- Able to communicate well with the investigator and to comply with the requirements of
the entire study.

- Provision of written informed consent to participate as shown by a signature on the
volunteer consent form.

- 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 during the study.

- Forced expiratory volume in 1 second (FEV1) = 80% of predicted normal for age, gender,
and height at Screening and Pre-dose.

- Normal intraocular pressure between 10 and 21 mm Hg.

- Male subjects who are sexually active must be willing to use effective barrier
contraception (e.g., condoms) during heterosexual intercourse from Baseline/Day 0
through completion of the study and continuing for at least 90 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 90 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
- Any prior exposure to GS-9411.

- 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 at Screening and at Day -1.

- Hemoglobin level < 130 g/L taken at Screening and at Day -1.

- Serum potassium > 5 mEq/L taken at Screening and at Day -1.

- Poor venous access.

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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
15
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/ct2/show/NCT00951522
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