Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria

1. Serum total testosterone < 300 ng/dL based on two blood samples obtained between 6 and 10 AM on two separate occasions at least 48 hours apart. Previously documented total testosterone results obtained within 6 weeks of Study Day -2 may be used during screening for subjects not currently on androgen replacement therapy, or following washout of androgen replacement therapy.

2. Subjects naïve to androgen replacement or washout of 12 weeks following intramuscular androgen injections; 4 weeks following topical or buccal androgens; and 3 weeks following oral androgens. Washout should be completed by Study Day -2.

3. Subject is judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12 lead electrocardiogram (ECG) performed at Screening.

4. Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria

1. History of significant sensitivity or allergy to any drug, including androgens, castor oil or product excipients.

2. Previous history or current or suspected prostate or breast cancer, and/or previous history of cancer (except basal cell carcinoma of the skin).

3. Subjects not on a stable medication regimen for at least three months for the treatment of a chronic condition such as hypertension, hyperlipidemia or diabetes mellitus.

4. Use of known inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study.

5. Use of any drug within 5 half-lives of the last dose in the past 6 months prior to Study Day -2 without principal investigator and/or sponsor approval.

6. Receipt of any drug by injection within 30 days or 10 half-lives (which ever is longer) prior to study drug administration without principal investigator and/or sponsor approval.