Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: Denosumab (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s): MD, Study Director, Affiliation: Amgen
Summary
This is a phase 1b, open-label, single dose study in healthy male subjects. Approximately 12
healthy male subjects will receive a subcutaneous injection of denosumab on Day 1. Subjects
will be followed by a 105 day treatment-free follow-up period.
Clinical Details
Official title: An Open-label Study to Evaluate the Concentration of Denosumab in Seminal Fluid After a Single Subcutaneous Injection in Healthy Men
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Maximum Observed Concentration (Cmax) of Denosumab in Seminal FluidTime to Maximum Observed Concentration (Tmax) of Denosumab in Seminal Fluid Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Seminal Fluid
Secondary outcome: Maximum Observed Concentration (Cmax) of Denosumab in SerumTime to Maximum Observed Concentration (Tmax) of Denosumab in Serum Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Serum Ratio of Maximum Seminal Fluid Concentration by the Serum Concentration (Cmax Ratio) Ratio of Seminal Fluid AUC by Serum AUC for the 106 Day Dosing Period Ratio of Denosumab Seminal Fluid Concentration Over the Denosumab Serum Concentration at the Last Study Time Point (Day 106).
Eligibility
Minimum age: 40 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
Subject has provided informed consent; Healthy male between ≥40 to ≤ 65 years of age
(inclusive) at the time of enrollment; Subject must be willing and able to produce a semen
sample on seven separate study visits; Subject must be willing to refrain from ejaculation
for a 48 hour period prior to each sample collection;
Exclusion Criteria:
Any condition or drug therapy that might interfere with the subjects ability to ejaculate
and produce a semen sample; Clinically significant abnormality during the screening
physical examination, ECG, or laboratory evaluation; Known history of blood in urine or
semen; Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental
procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months),
poor oral hygiene, periodontal and/or pre-existing dental disease; Recent tooth extraction
(within 6 months of screening visit); Evidence of hypocalcemia at screening; Known vitamin
D deficiency; Malignancy (except non-melanoma skin cancers) within the last 5 years;
Positive for human immunodeficiency virus (HIV) at screening or known diagnosis of AIDS;
Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or
detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) at
screening (indicative of active Hepatitis C - screening is generally done by Hepatitis C
Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive);
History of hypersensitivity or allergic reaction to mammalian cell derived drug products
or sensitivity to any of the products or components to be administered during dosing;
Known intolerance to calcium or vitamin D supplements; Subject previously has entered this
study or has been previously exposed to denosumab in the past 12 months; Has donated or
lost ≥ 400 mL of blood or plasma within 8 weeks prior to screening; Positive urine screen
for alcohol and/or potential drugs of abuse at screening unless medication is prescribed
by a physician and approved by the Investigator and Amgen; Known alcohol abuse or use of
illicit drugs within 12 months of enrollment; Subject is unwilling or unable to limit
alcohol consumption throughout the course of the study. Alcohol is prohibited 24 hours
prior to screening and administration of investigational product. Alcohol is limited to no
more than 2 drinks per day for the duration of the study; where a standard drink is
equivalent to 12 ounces of regular beer, 8-9 ounces of malt liquor, 5 ounces of wine, or
1. 5 ounces of 80 proof distilled spirits; Currently receiving treatment in another
investigational device or drug study, or less than 30 days or 5 half-lives (whichever is
longer) since ending treatment on another investigational device or drug study(s). Other
investigational procedures while participating in this study are excluded; Use of any
non-Amgen approved over-the-counter or prescription medications, within the 14 days or 5
half-lives (whichever is longer), prior to receiving the dose of denosumab. Acetaminophen
(up to 2 g per day) for analgesia and hormone replacement therapy (eg, androgen, thyroid)
will be allowed. Other medications may be approved following review by the Principal
Investigator and the Amgen Medical Monitor. Written documentation of this review and Amgen
acknowledgement is required for subject participation; Subject likely to not be available
to complete all protocol-required study visits or procedures, and/or to comply with all
required study procedures to the best of the subject and Investigator's knowledge; Subject
has any kind of disorder that, in the opinion of the Investigator, may compromise the
ability of the subject to give written informed consent and/or to comply with all required
study procedures; History or evidence of any other clinically significant disorder,
condition or disease that, in the opinion of the Investigator or Amgen physician, if
consulted, would pose a risk to subject safety or interfere with the study evaluation,
procedures or completion
Locations and Contacts
Research Site, Overland Park, Kansas 66212, United States
Additional Information
AmgenTrials clinical trials website
Starting date: June 2013
Last updated: November 5, 2014
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