Trial Outcomes & Findings for Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose (NCT NCT01869686)

NCT ID: NCT01869686

Last Updated: 2014-11-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: Days 1, 10, 22, 36, 50, 78 and 106
• Results posted on: 2014-11-06

Participant Flow

First patient enrolled 17 June 2013; last patient enrolled 17 June 2013.

Participant milestones

Measure	Denosumab Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Concentration of Denosumab in Seminal Fluid in Healthy Men After a Single Subcutaneous Dose

Baseline characteristics by cohort

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Age, Continuous	56.6 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants
Race/Ethnicity, Customized Black (or African American)	0 participants n=5 Participants
Race/Ethnicity, Customized Mixed race	0 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants
Race/Ethnicity, Customized Othe	1 participants n=5 Participants
Body Mass Index (BMI)	27.73 kg/m^2 STANDARD_DEVIATION 4.21 • n=5 Participants

PRIMARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population

Outcome measures

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Maximum Observed Concentration (Cmax) of Denosumab in Seminal Fluid	100 ng/mL Standard Deviation 81.9

PRIMARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population with available data

Outcome measures

Measure	Denosumab n=11 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Time to Maximum Observed Concentration (Tmax) of Denosumab in Seminal Fluid	21 days Full Range 81.9 • Interval 8.0 to 49.0

PRIMARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population

The area under the denosumab seminal fluid concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.

Outcome measures

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Seminal Fluid	5220 days*ng/mL Standard Deviation 4880 • Interval 8.0 to 49.0

SECONDARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population

Outcome measures

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Maximum Observed Concentration (Cmax) of Denosumab in Serum	6170 ng/mL Standard Deviation 2070

SECONDARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population

Outcome measures

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Time to Maximum Observed Concentration (Tmax) of Denosumab in Serum	8.0 days Full Range 81.9 • Interval 7.9 to 21.0

SECONDARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population

The area under the denosumab serum concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.

Outcome measures

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Serum	333000 days*ng/mL Standard Deviation 122000 • Interval 8.0 to 49.0

SECONDARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population with available data

The ratio of maximum denosumab seminal fluid concentration over the denosumab serum concentration at the corresponding time point (Cmax Ratio)

Outcome measures

Measure	Denosumab n=11 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Ratio of Maximum Seminal Fluid Concentration by the Serum Concentration (Cmax Ratio)	0.0217 ratio Standard Deviation 0.0154 • Interval 8.0 to 49.0

SECONDARY outcome

Timeframe: Days 1, 10, 22, 36, 50, 78 and 106

Population: Pharmacokinetic population

The ratio of denosumab seminal fluid AUC over denosumab serum AUC for the 106-day dosing period.

Outcome measures

Measure	Denosumab n=12 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Ratio of Seminal Fluid AUC by Serum AUC for the 106 Day Dosing Period	0.0170 ratio Standard Deviation 0.0148 • Interval 8.0 to 49.0

SECONDARY outcome

Timeframe: Day 106

Population: Pharmacokinetic population with available data

Outcome measures

Measure	Denosumab n=11 Participants Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
Ratio of Denosumab Seminal Fluid Concentration Over the Denosumab Serum Concentration at the Last Study Time Point (Day 106).	0.0197 ratio Standard Deviation 0.0318 • Interval 8.0 to 49.0

Adverse Events

Denosumab 60 mg SC

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Denosumab 60 mg SC n=12 participants at risk
Ear and labyrinth disorders Vertigo positional	8.3% 1/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Denosumab 60 mg SC n=12 participants at risk
Gastrointestinal disorders Rectal haemorrhage	8.3% 1/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	8.3% 1/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	16.7% 2/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	16.7% 2/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus	8.3% 1/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercholesterolaemia	8.3% 1/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypophosphataemia	8.3% 1/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 2/12 • 78 days Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER