A trial comparing ACP-011 administered as a single dose via a syringe and needle versus an auto-injector
- Conditions
- Growth failure in children due to Growth Hormone DeficiencyMetabolic and Endocrine - Other endocrine disorders
- Registration Number
- ACTRN12617001471370
- Lead Sponsor
- Ascendis Pharma Endocrinology Division A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 28
1) Healthy Male Adults aged between 18 and 65 years at time of informed consent
2) Body weight between 60.50 and 73.90 kg
3) Body mass index (BMI) between19 and 29 kg/m2
4) Considered to be in good general health at screening as determined by investigator
5) Able to comply with all protocol requirements.
6) Able to provide written informed consent.
1) History of clinically significant (in the opinion of the investigator) endocrine disease; history or presence of endocrine tumors, thyroid disease, diabetes, or impaired glucose tolerance.
2) History of malignancy of any organ system (other than localized basal or squamous cell carcinomas of the skin), treated or untreated within the past 5 years.
3) Clinically significant (in the opinion of the investigator) history of neurological, cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease, glaucoma, a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
4) On a 12-lead ECG, the subject has any of the following at screening, confirmed by repeat assessment:
- PR greater than or equal to 221 ms
- QRS greater than or equal to 120 ms
- QTcF greater than or equal to 451 ms
5) Systolic blood pressure <90 mmHg and >140 mmHg; diastolic blood pressure <40 mmHg and > 90 mmHg
6) Known or suspected HIV-positive status
7) Known or suspected infection with hepatitis B or C
8) Use of any prescription or over-the-counter medications (including herbal or nutritional supplements) within 14 days before the first dose of study drug.
9) Consumption of alcohol-containing products within 48 hours before dosing with study drug.
10) Social smokers who are otherwise healthy may be enrolled if they have not used nicotine containing products within 2 weeks prior to dosing.
11) History of alcohol or drug abuse
12) Strenuous activity or contact sports within 24 hours before dosing with study drug or during the study.
13) Donation of blood or blood products >450 mL within 30 days before dosing with study drug.
14) Presence of contraindications to hGH treatment
15) Known hypersensitivity to the components of the trial medication
16) Any medical abnormality unless approved by Medical Monitor
17) History of relevant drug and/or allergies (ie, allergy to ACP-011, or excipients, or any significant food allergy that would preclude a standard diet in the clinic).
18) Participation in drug trial in which receipt of a study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to study entry
19) Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pharmacokinetic (PK) profile of ACP-011, measured as Cmax and Area Under the Curve (AUC) of hGH when administered by syringe and needle versus an auto-injector.[For hGH, the following PK parameters will be estimated:<br><br>Maximum observed serum concentration (Cmax)<br>Area under the curve (AUC) from time 0 (predose) to the time of the last measureable concentration postdose<br>AUC from time 0 (predose) to 168 hours postdose <br>AUC from time 0 (predose) extrapolated to infinity <br><br>PK blood samples will be drawn at 30-60 and at 5-15 minutes predose and at 2, 4, 8, 12, 16, 24, 30, 36, 48, 60, 72, 96, 120, 144, and 168 hours post dose (during inpatient stay).]
- Secondary Outcome Measures
Name Time Method