A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00951522
• Date of registration: 03/08/2009
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• 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
• Date of first enrolment: September 2009
• Target sample size: 15
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00951522
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Peter Hodsman, MD
• Affiliation: Nucleus Network Ltd

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Mucociliary Clearance

Airway Hydration

Intervention(s)

Drug: GS-9411

Drug: Placebo

Primary Outcome(s)

Safety and Tolerability of 4 escalating doses of GS-9411 in healthy male volunteers [Time Frame: 7 Days]

Secondary ID(s)

GS-US-221-0102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors