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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00999531
Date of registration: 20/10/2009
Prospective Registration: No
Primary sponsor: Gilead Sciences
Public title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers
Scientific title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Volunteers
Date of first enrolment: October 2009
Target sample size: 24
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00999531
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 1
Countries of recruitment
Australia
Contacts
Name:     Peter Hodsman, MD
Address: 
Telephone:
Email:
Affiliation:  Nucleus Network Ltd
Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females, 18 to 65 years of age

- No clinically important abnormal physical findings at Screening

- No clinically relevant abnormalities in the results of laboratory evaluation at
Screening

- Must test negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and human
immunodeficiency virus (HIV) at Screening

- Normal electrocardiogram (ECG) at Screening

- Normal blood pressure (BP) and heart rate (HR) in the absence of any medications for
body weight between 50 and 125 kg and within ± 15% of ideal body weight or body mass
index (BMI) between 18 and 28 kg/m2 at Screening

- 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

- Nonsmokers of at least 180 days (6 months) duration (< 10 pack/year history) prior to
Screening

- 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 hours
prior to Day -5 and during the study

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

- Normal intraocular pressure (IOP) between 10 and 21 mm Hg at Screening

- Male subjects who are sexually active must be willing to use effective barrier
contraception (e.g., condoms) during heterosexual intercourse from Day -5 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 -5 through completion of the
study and continuing for at least 90 days from the date of last dose of study drug

- Non-lactating females. Females on hormone replacement therapy (estrogen/progesterone)
or contraceptive therapy must be stabilized on a product and dose for at least 90
days prior to Screening

- Females must have a negative serum gonadotropin pregnancy test at Screening and Day
-1

- Nonpregnant females of childbearing potential must agree to use highly effective (<1%
failure rate) contraception during heterosexual intercourse from Screening,
throughout the study, and for at least 30 days following the last dose of study drug

Exclusion Criteria:

- Any prior exposure to GS-9411

- Administration of any investigational drug in the period 84 days (12 weeks) prior to
Screening; 112 days (16 weeks) if the previous investigational drug was a new
chemical entity

- A need for any medication during the period 0 to 5 days prior to Screening, 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 56 days (8 weeks) of Screening

- Donation or loss of greater than 400 mL of blood in the period 84 days (12 weeks)
prior to Screening

- Serious adverse reaction or hypersensitivity to any drug

- Presence or history of any pulmonary diseases (e.g., asthma, emphysema, chronic
bronchitis, CF, bronchiectasis)

- Lactating females

- History of glaucoma

- 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 28 days (or 5 half-lives of inducing/inhibiting agent, whichever is longer) of
Screening

- Major surgery within 180 days (6 months) of the start of this study

- Subjects who have experienced a significant upper or lower respiratory tract
infection within the 42 days (6 weeks) prior to Screening

- 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 the 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Airway Hydration
Mucociliary Clearance
Cystic Fibrosis
Intervention(s)
Drug: Placebo
Drug: GS-9411
Primary Outcome(s)
Safety and tolerability of multiple doses of inhaled GS-9411 in healthy volunteers [Time Frame: 21 Days]
Secondary Outcome(s)
Assess the pharmacokinetics of GS-9411 and its metabolites [Time Frame: 21 Days]
Secondary ID(s)
GS-US-221-0107
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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