Trial Outcomes & Findings for Pharmacokinetic Study of Subcutaneous Testosterone Enanthate (NCT NCT02233751)

NCT ID: NCT02233751

Last Updated: 2019-04-19

Results Overview

Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: Maximum serum concentrations occurring during an 8 days study window
• Results posted on: 2019-04-19

Participant Flow

Pharmacokinetics of single doses of Testosterone Enanthate administered via a drug-auto injector combination product in Healthy Male Subjects

Two dose groups, Testosterone Enanthate 50 mg and Testosterone Enanthate 200 mg , were evaluated in parallel with 6 subjects in each dose group.

Participant milestones

Measure	Testosterone Enanthate 50 mg Testosterone enanthate auto-injector * 50 mg SC injection	Testosterone Enanthate 200 mg Testosterone enanthate auto-injector * 200 mg SC injection
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Baseline characteristics by cohort

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg	Total n=12 Participants Total of all reporting groups
Age, Continuous	38.0 years STANDARD_DEVIATION 11.54 • n=5 Participants	37.5 years STANDARD_DEVIATION 10.84 • n=7 Participants	37.8 years STANDARD_DEVIATION 10.68 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Maximum serum concentrations occurring during an 8 days study window

Population: Healthy normal male volunteers

Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate

Outcome measures

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg
Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate Serum testosterone	773.7 ng/dL Standard Deviation 121.26	1487.0 ng/dL Standard Deviation 405.34
Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate Serum testosterone enanthate	49.25 ng/dL Standard Deviation 6.90	267.33 ng/dL Standard Deviation 75.77

PRIMARY outcome

Timeframe: 168 hrs

AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);

Outcome measures

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg
Area Under the Concentration-time Curve From Time Zero to Time t TT	103731.5 (ng⋅hr/dL) Standard Deviation 12591.81	176112.8 (ng⋅hr/dL) Standard Deviation 47349.64
Area Under the Concentration-time Curve From Time Zero to Time t TE	6122.2 (ng⋅hr/dL) Standard Deviation 929.12	33535.5 (ng⋅hr/dL) Standard Deviation 9977.18

PRIMARY outcome

Timeframe: time zero to infinity

AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity

Outcome measures

Measure	Testosterone Enanthate 50 mg n=2 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=3 Participants Testosterone enanthate auto-injector 200 mg
Area Under the Concentration-time Curve From Time Zero to Infinity TT	279062.2 (ng⋅hr/dL) Standard Deviation 35973.32	362627.4 (ng⋅hr/dL) Standard Deviation 138773.09
Area Under the Concentration-time Curve From Time Zero to Infinity TE	NA (ng⋅hr/dL) Standard Deviation NA AUC(0-inf) is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \<0.8.	62497.5 (ng⋅hr/dL) Standard Deviation 24618.09

SECONDARY outcome

Timeframe: The sample time of Cmax during a 168 hour sampling interval

tmax = Time to reach maximum concentration

Outcome measures

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg
Time to Maximum Concentration (Tmax)(hr) TT	40.51 hours Standard Deviation 52.95	19.00 hours Standard Deviation 7.75
Time to Maximum Concentration (Tmax)(hr) TE	82.01 hours Standard Deviation 53.88	74.00 hours Standard Deviation 57.01

SECONDARY outcome

Timeframe: 168 hours

t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value

Outcome measures

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg
Half-life (t 1/2)(hr) TT	261.73 hours Standard Deviation 99.04	131.75 hours Standard Deviation 28.05
Half-life (t 1/2)(hr) TE	NA hours Standard Deviation NA Half-life (t 1/2) is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \<0.8.	133.00 hours Standard Deviation 67.85

SECONDARY outcome

Timeframe: 168 hours

Clearance - volume of plasma from which TT/TE is completely removed per unit time

Outcome measures

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg
Clearance CL/F (L/hr) TT	18.07 L/hr Standard Deviation 2.33	60.46 L/hr Standard Deviation 21.21
Clearance CL/F (L/hr) TE	NA L/hr Standard Deviation NA Clearance - CL/F is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \<0.8.	352.84 L/hr Standard Deviation 127.58

SECONDARY outcome

Timeframe: 168 hours

Vd/F (L) = Apparent volume of distribution

Outcome measures

Measure	Testosterone Enanthate 50 mg n=6 Participants Testosterone enanthate auto-injector 50 mg	Testosterone Enanthate 200 mg n=6 Participants Testosterone enanthate auto-injector 200 mg
Vd/F (L) TT	6655.8 Liters Standard Deviation 1702.04	10959.5 Liters Standard Deviation 2040.99
Vd/F (L) TE	NA Liters Standard Deviation NA Vd/F is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is \<0.8.	62366.4 Liters Standard Deviation 23950.96

Adverse Events

Treatment A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment A n=6 participants at risk Testosterone enanthate auto-injector (SC injection) Treatment A	Treatment B n=6 participants at risk Testosterone enanthate auto-injector (SC injections) Treatment B
General disorders Injection site pain	0.00% 0/6 • 14 days Safety assessments included adverse events and injection site assessments.	16.7% 1/6 • Number of events 1 • 14 days Safety assessments included adverse events and injection site assessments.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • 14 days Safety assessments included adverse events and injection site assessments.	0.00% 0/6 • 14 days Safety assessments included adverse events and injection site assessments.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • 14 days Safety assessments included adverse events and injection site assessments.	0.00% 0/6 • 14 days Safety assessments included adverse events and injection site assessments.

Additional Information

Jonathan Jaffe, MD

Antares Pharma, Inc.

Phone: 609-359-3020

Email: jjaffe@antarespharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER