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The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting (Treatment A) | Experimental | Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state |
|
| Very low fat diet (Treatment B) | Experimental | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat). |
|
| Low fat diet (Treatment C) | Experimental | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat). |
|
| Normal diet (Treatment D) | Experimental | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat). |
|
| High fat diet (Treatment E) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral testosterone undecanoate (containing 300 mg T) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25. | 25 hour serial blood draws separated by 4 to 10 days of washout between treatments. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Swerdloff, MD | LABiomedical Research Institute at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LABiomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States | ||
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Sixteen subjects (8 at each study center) were enrolled. A total of 72 subjects were screened (16 subjects at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and 56 subjects were screened at Anapharm, beginning on April 3, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ABCDE | Fasting (Treatment A) followed by dose-associated breakfast meals comprised of ~ 800 calories consisting of very low fat (6-10% fat; Treatment B), low fat (20% fat; Treatment C), "normal diet" (30% fat; Treatment D), and high fat (50% fat; Treatment E). Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days. |
| FG001 | Sequence BDCEA | Dose-associated breakfast meals comprised of ~ 800 calories consisting of very low fat (6-10% fat; Treatment B), followed by "normal diet" (30% fat; Treatment D), low fat (20% fat; Treatment C), high fat (50% fat; Treatment E) and fasting (Treatment A). Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days. |
| FG002 | Sequence CBEDA | Dose-associated breakfast meals comprised of ~ 800 calories consisting of low fat (20% fat; Treatment C), followed by very low fat (6-10% fat; Treatment B), high fat (50% fat; Treatment E) "normal diet" (30% fat; Treatment D), and fasting (Treatment A). Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days. |
| FG003 | Sequence DBAEC | Dose-associated breakfast meals comprised of ~ 800 calories consisting of "normal diet" (30% fat; Treatment D), followed by very low fat (6-10% fat; Treatment B), fasting (Treatment A), high fat (50% fat; Treatment E) and low fat (20% fat; Treatment C), Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cross over design in which each enrolled subject participated in each arm in a randomized order.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state (Treatment A) and followed by a dose-associated breakfast meal comprised of ~800 calories consisting of very low fat (6-10% fat, Treatment B), low fat (20% fat, Treatment C), normal diet (30% fat, Treatment D) and high fat (50% fat, Treatment E). Participants were randomized to one of the 4 treatment sequences (ABCDE, BDCEA, CBEDA, OR DBAEC). Oral testosterone undecanoate (containing 300 mg T) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet | PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25. | PK population | Posted | Geometric Mean | Standard Deviation | ng/dL | 25 hour serial blood draws separated by 4 to 10 days of washout between treatments. |
|
3 months
Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fasting | Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state Oral testosterone undecanoate (containing 300 mg T) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otorrhoea | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert E. Dudley, PhD, CEO and President | Clarus Therapeutics, Inc. | 847-562-4300 | rdudley@clarustherapeutics.com |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.
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Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat).
|
| Anapharm, Inc. |
| Québec |
| Quebec |
| G1P 0A2 |
| Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat). Oral testosterone undecanoate (containing 300 mg T) |
| OG002 | Low Fat Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat). Oral testosterone undecanoate (containing 300 mg T) |
| OG003 | Normal Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat). Oral testosterone undecanoate (containing 300 mg T) |
| OG004 | High Fat Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat). Oral testosterone undecanoate (containing 300 mg T) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Very Low Fat Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with very low fat (6-10% fat). Oral testosterone undecanoate (containing 300 mg T) | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Low Fat Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with low fat (20% fat). Oral testosterone undecanoate (containing 300 mg T) | 0 | 16 | 0 | 16 | 2 | 16 |
| EG003 | Normal Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with normal fat (30% fat). Oral testosterone undecanoate (containing 300 mg T) | 0 | 16 | 0 | 16 | 4 | 16 |
| EG004 | High Fat Diet | Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of ~800 calories with high fat (50% fat). Oral testosterone undecanoate (containing 300 mg T) | 0 | 16 | 0 | 16 | 3 | 16 |
| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
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| Eye swelling | Eye disorders | MedDRA | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
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| Otopharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
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