Phase 1
Completed N=151
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
Healthy Male Subjects
Source: ClinicalTrials.gov NCT05275010 ↗
Enrolled (actual)
151
Serious AEs
0.7%
Results posted
Sep 2024
Primary outcomePrimary: Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Pertuzumab — 1671.2; 1674.6 μg*day/mL
Summary
This is a randomized, open-label, 2-arm, parallel-group, single-dose, multi-center study in healthy male subjects to investigate the comparability of the pharmacokinetics of the fixed-dose combination of pertuzumab and trastuzumab administered subcutaneously using the proprietary on-body delivery system or a handheld syringe with hypodermic needle.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Pertuzumab |
1671.2; 1674.6 | — |
| PRIMARY Area Under the Time-Concentration Curve From the Start of Dosing to 63 Days (AUC0-62) for Serum Trastuzumab |
1341.2; 1347.1 | — |
| PRIMARY Maximum Serum Concentration (Cmax) of Pertuzumab |
63.4; 65.8 | — |
| PRIMARY Maximum Serum Concentration (Cmax) of Trastuzumab |
59.8; 62.0 | — |
| SECONDARY Observed Serum Concentration of Pertuzumab on Day 22 |
34.2; 34.6 | — |
| SECONDARY Observed Serum Concentration of Trastuzumab on Day 22 |
29.9; 29.5 | — |
| SECONDARY Observed Serum Concentration of Pertuzumab on Day 63 |
6.23; 6.23 | — |
| SECONDARY Observed Serum Concentration of Trastuzumab on Day 63 |
1.00; 1.00 | — |
| SECONDARY Area Under the Time-Concentration Curve From the Start of Dosing Extrapolated to Infinity (AUC0-∞) for Serum Pertuzumab |
1930; 1860 | — |
| SECONDARY Area Under the Time-Concentration Curve From the Start of Dosing Extrapolated to Infinity (AUC0-∞) for Serum Trastuzumab |
1440; 1410 | — |
| SECONDARY Observed Time to Maximum Serum Concentration (Tmax) of Pertuzumab |
4.00; 4.00 | — |
| SECONDARY Observed Time to Maximum Serum Concentration (Tmax) of Trastuzumab |
4.01; 4.00 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) of Pertuzumab |
15.6; 15.1 | — |
| SECONDARY Terminal Elimination Half-Life (t1/2) of Trastuzumab |
8.93; 8.43 | — |
| SECONDARY Apparent Drug Clearance (CL/F) of Pertuzumab |
347; 361 | — |
| SECONDARY Apparent Drug Clearance (CL/F) of Trastuzumab |
469; 481 | — |
| SECONDARY Apparent Volume of Distribution (Vd/F) of Pertuzumab |
7670; 7730 | — |
| SECONDARY Apparent Volume of Distribution (Vd/F) of Trastuzumab |
6320; 6030 | — |
| SECONDARY Summary of the Number of Participants With at Least One Adverse Event, With Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) |
70; 71; 0; 0; 1; 0 | — |
| SECONDARY Change From Baseline Left Ventricular Ejection Fraction (LVEF) Over Time |
61.55; 60.99; 0.10; -0.94; -0.87; -0.20 | — |
| SECONDARY Change From Baseline Pulse Rate Over Time |
58.24; 59.30; 7.04; 6.51; 1.80; 4.34 | — |
| SECONDARY Change From Baseline Respiratory Rate Over Time |
15.71; 15.50; -0.22; -0.03; 0.00; 0.04 | — |
| SECONDARY Change From Baseline Systolic Blood Pressure Over Time |
118.33; 116.09; -1.44; 0.61; 4.55; 4.99 | — |
| SECONDARY Change From Baseline Diastolic Blood Pressure Over Time |
70.50; 70.38; -1.99; -2.12; 3.04; 2.62 | — |
| SECONDARY Number of Participants With Normal or Abnormal Electrocardiogram Results at Baseline and Post-Baseline Anytime, as Determined by the Investigator |
48; 42; 24; 32; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events Based on Laboratory Test Abnormalities |
0; 1; 0; 1; 1; 0 | — |
| SECONDARY Pain Score at the Injection Site, Assessed by the Participant Using the 100-millimetre (mm) Visual Analog Scale |
0.68; 0.50; 6.85; 8.95; 8.56; 5.04 | — |
| SECONDARY Number of Participants With Skin Irritation and Sensitization Reactions at the Injection Site, as Reported by Investigators in the Device Monitoring Questionnaire |
74; 62; 12; 74; 73; 1 | — |
| SECONDARY Number of Participants by Their Ratings of the Comfort of Wearing the On-Body Delivery System Device, as Reported in the Device Monitoring Questionnaire |
74; 0; 0; 73; 1; 0 | — |
| SECONDARY Number of Healthcare Professionals by Their Responses to the Device Monitoring Questionnaire Regarding Use of the On-Body Delivery System Device |
74; 0; 74; 0; 74; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male subjects age 18-45 years at time of signing Informed Consent Form
- Ability to comply with the study protocol
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, during the treatment period and for 7 months after the dose of PH FDC SC
- A body mass index (BMI) between 18 and 32 kilograms per metre squared (kg/m2), inclusive
- Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions in the area for intended injection on the thighs
- Baseline LVEF≥55% measured by echocardiogram (ECHO)
- No history of hypersensitivity or confirmed, clinically significant and clinically relevant allergic reactions, either spontaneously or following any drug administration
- No history of any clinically significant and clinically relevant cardiac condition
- No history of previous anticancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
- No apparent family history of clinically significant and clinically relevant hypersensitivity, allergy, and severe cardiac diseases
- No contraindications from detailed medical and surgical history and physical examinations
- No previous enrollment in this study protocol and no concurrent enrollment in any other study protocol
Exclusion Criteria
- Positive urine test for drugs of abuse as per local standard (for alcohol abuse, positive breath test is also acceptable)
- Positive test result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) 1 or 2, showing: History of exposure to HBV, HCV, or HIV; or Active viral hepatitis infection (HBV or HCV) or HIV infection
- Systolic blood pressure ≥140 millimetres of mercury (mmHg) or 90 mmHg or 3 months) with corticosteroids (dose ≥10 mg/day methylprednisolone), excluding inhaled corticosteroids
- Receipt of intravenous antibiotics for infection within 7 days prior to enrollment into the study
Data sourced from ClinicalTrials.gov (NCT05275010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.