A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers
This study is currently recruiting participants.
Verified by Gilead Sciences, October 2009
First Received: October 20, 2009 Last Updated: October 21, 2009 History of Changes
| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00999531 |
Purpose The purpose of this study is to evaluate the safety and tolerability of repeated doses of GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis Mucociliary Clearance Airway Hydration | Drug: GS-9411 Drug: Placebo | Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Safety and tolerability of multiple doses of inhaled GS-9411 in healthy volunteers [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the pharmacokinetics of GS-9411 and its metabolites [ Time Frame: 21 Days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental GS-9411 9.6 mg | Drug: GS-9411 Inhaled GS-9411 dissolved in sterile saline |
| 2: Experimental GS-9411 4.8 mg | Drug: GS-9411 Inhaled GS-9411 dissolved in sterile saline |
| 3: Placebo Comparator Placebo, sterile saline | Drug: Placebo Inhaled Placebo, sterile saline |
Detailed Description:
GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary clearance in patients with cystic fibrosis. This study is evaluating the safety and tolerability of 2 dose levels of GS-9411 as an inhaled product, compared to a matched placebo, administered twice daily for 14 days.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 100 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 (<>
- 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%>
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)
- 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 <>
- Serum potassium > 5 mEq/L taken at Screening and at Day -1
- Poor venous access
Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00999531
Contacts
| Contact: Bianca Scott | 613-9076-9825 | b.scott@nucleusnetwork.com.au |
Locations
| Australia, Victoria | |
| Nucleus Network, Ltd. | Recruiting |
| Melbourne, Victoria, Australia | |
| Principal Investigator: Peter Hodsman, MD | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Principal Investigator: | Peter Hodsman, MD | Nucleus Network Ltd |
More Information No publications provided
| Responsible Party: | Gilead Sciences, Inc. ( Thomas O'Riordan, MD ) |
| Study ID Numbers: | GS-US-221-0107 |
| Study First Received: | October 20, 2009 |
| Last Updated: | October 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00999531 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Gilead Sciences:
| Cystic Fibrosis CF Mucociliary Clearance Epithelial Sodium Channel Inhibitor | ENaC Inhibitor Airway Hydration Amiloride |
Additional relevant MeSH terms:
| Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Lung Diseases | Infant, Newborn, Diseases Pancreatic Diseases Cystic Fibrosis Fibrosis |
ClinicalTrials.gov processed this record on October 27, 2009
http://www.clinicaltrials.gov/ct2/show/NCT00999531?term=cystic+fibrosis&recr=Open&rcv_d=14
