Healthy
Conditions
Keywords
sumatriptan, Intraject, Local Site Reactions
Brief summary
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
Detailed description
This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.
Interventions
DRUGSumatriptan
injection
Sponsors
Zogenix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female subjects of child-bearing potential must agree to use acceptable birth control * Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection * Fluent in the spoken and written English language * Provide written informed consent to participate in the study and be willing to comply with the study procedures * Non-tobacco user for at least 12 months prior to screening (all types of tobacco, including cigars)
Exclusion criteria
* A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease * Other significant underlying cardiovascular diseases including uncontrolled hypertension * Hemiplegic or basilar migraine * A history or diagnosis of severe hepatic or renal impairment * A history of epilepsy or seizure or other serious neurologic condition * A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs * A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications * Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation * Pregnancy or breast-feeding * Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose | Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 31 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
Time frame: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants at -15 Min Pre-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |
| All Participants at -15 Min Pre-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 0 injections |
| All Participants at -15 Min Pre-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 0 injections |
| All Participants at -15 Min Pre-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 0 injections |
| All Participants Immediately Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 9 injections |
| All Participants Immediately Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 0 injections |
| All Participants Immediately Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 51 injections |
| All Participants Immediately Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 39 injections |
| 1 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |
| 1 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 39 injections |
| 1 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 0 injections |
| 1 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 18 injections |
| 4 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |
| 4 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 1 injections |
| 4 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 0 injections |
| 4 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 37 injections |
| 8 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 18 injections |
| 8 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 0 injections |
| 8 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 3 injections |
| 8 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |
| 24 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 13 injections |
| 24 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 0 injections |
| 24 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 4 injections |
| 24 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |
| 48 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 2 injections |
| 48 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |
| 48 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 0 injections |
| 48 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 10 injections |
| 72 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bruising present | 1 injections |
| 72 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Swelling present | 0 injections |
| 72 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Erythema present | 0 injections |
| 72 hr Post-dose | The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema). | Injections with Bleeding present | 0 injections |