Pharmacokinetics in Healthy AdultsPhase 2/3NCT02561442
Crossover Study to Compare the Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone Administration
A Phase 2/3 study testing ceftriaxone in people with Pharmacokinetics in Healthy Adults, run by scPharmaceuticals, Inc..
Trial summary
The proposed study aims to assess the time above MIC (4 mg/mL), and the pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone administered as a constant IV infusion over 0.5 hours. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics in Healthy Adults
- What is being tested?
- ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects between 18 and 65 years of age inclusive.
- Subjects must have body weight of 45.5 to 105 kg inclusive and body mass index (BMI) ≤34 kg/m2.
- Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agree, from the time of signing the informed consent or 14 days prior to Baseline until Follow-up, to use TWO (2) of the following forms of contraception: a IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner, OR abstinence. For all females, a pregnancy test result must be negative at Screening and Baseline/Day 0
- Males agree from the time of Baseline/Day 0 until Follow-up, to use TWO (2) forms of contraception: ONE must be a male condom with spermicide; the second may be ONE of the following: his female partner uses either an IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, oral contraceptives; OR abstinence
- Subject has normal (or abnormal and clinically insignificant) laboratory values at screening.
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- Subject is medically normal with no significant abnormal findings at the Baseline physical examination.
- Subjects must have Baseline values of the following laboratory tests as specified:
- AST, ALT, alkaline phosphatase (ALP), total bilirubin, and creatinine <1.1 ULN
- Platelet count >100 X 103/µL
- Neutrophil count >1.0 X 103/µL
- Subject has the ability to understand the requirements of the study and is willing to comply with all study procedures.
- Subject has not consumed and agrees to abstain from taking any vitamin or dietary supplements or non-prescription drugs (except as authorized by the Investigator and Medical Monitor) for 3 days prior to CRU admission through Follow-Up, with the exception of oral contraceptives.
- Subject has not consumed and agrees to abstain from taking any prescription drugs (except as authorized by the Investigator and Medical Monitor) during the 14 days prior to CRU admission through Follow-Up.
- Subject has not consumed and agrees to abstain from consuming grapefruit, grapefruit juice, or juices containing grapefruit, or Seville oranges during the 3 days prior to CRU admission through Follow-Up.
- Subject agrees to abstain from using alcohol from 48 hours prior to Screening and CRU admission through CRU discharge for each period.
Who cannot join
- Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease, or current clinically significant infection.
- History of chronic skin conditions requiring medical therapy.
- Clinically significant abnormalities at Screening or Baseline in safety laboratory tests.
- Corrected QT interval (QTc) greater than 450 msec for males and 470 msec for females as corrected by the Fridericia formula.
- Major surgery within 30 days prior to Screening.
- Administration of an investigational drug or implantation of investigational device, or participation in another trial, within 30 days prior to Screening.
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- Any surgical or medical condition which in the opinion of the investigator may interfere with participation in the study or which may affect the outcome of the study.
- Positive test for hepatitis B, hepatitis C, or HIV at Screening.
- Positive urine drug screen at Screening or Baseline.
- Tobacco users (includes users who stopped smoking £90 days prior to the screening evaluation). [Note: "Tobacco use" includes smoking and the use of snuff and chewing tobacco, and other nicotine or nicotine containing products.]
- History of alcohol abuse within 6 months prior to screening, as determined by the Investigator.
- Consumed alcohol within 48 hours of Screening or each CRU admission or have a positive alcohol test at Screening or any admission to the CRU.
- Known allergy cephalosporin class of antibiotics or penicillin.
- Female subject who is pregnant or lactating.
- Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to study drug administration.
- Subjects with hemoglobin (Hb) ≤10.5 g/dL
About this study
Official title: A Single-Dose, Randomized, Three-way, Partially Blinded Crossover Study to Compare the Pharmacokinetics and Bioavailability of Ceftriaxone Administered as a 1 Gram Intravenous Infusion, a 1 Gram Subcutaneous Infusion and a 2 Gram Subcutaneous Infusion in Healthy Adult Subjects
The proposed study aims to assess the time above MIC (4 mg/mL), and the pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone administered as a constant IV infusion over 0.5 hours. In addition, the study will compare the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2 g ceftriaxone administered subcutaneously
- Conditions
- Pharmacokinetics in Healthy Adults
- Being tested
- ceftriaxone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| IV ceftriaxone (0.5hr) 1 gm | Active comparator | ceftriaxone for injection, (total dose = 1.0 g) administered IV over 30 minutes via infusion pump (Open Label) Receives: Drug: ceftriaxone |
| subcutaneous ceftriaxone, (2hr), 1 gm | Experimental | ceftriaxone for injection, (total dose = 1.0 g) administered subcutaneous over 2 hours (Blinded). Receives: Drug: ceftriaxone |
| subcutaneous ceftriaxone, (2 hr), 2 gm | Experimental | ceftriaxone for injection, (total dose = 2.0 g) administered subcutaneous over 2 hours (Blinded). Receives: Drug: ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration
Cmax, observed by inspection of individual study participant plasma concentration time plots.
Measured: 48 hours
Time of observed maximum plasma concentration
Tmax, obtained directly from the observed concentration-time data
Measured: 48 hours
Area under the plasma concentration-time curve
AUClast: AUC from time 0 to the last measureable non-zero concentration, calculated by a combination of linear and logarithmic trapezoidal methods
Measured: 48 hours
Area under the concentration time curve, extrapolated to infinity
AUCinf: Area under the concentration time curve from time 0 extrapolated to infinity, calculated as AUClast + Clast/λz
Measured: 48 hours
Terminal phase elimination rate constant
Terminal phase elimination rate constant, estimated by linear regression of logarithmically transformed concentration versus time data.
Measured: 48 hours
Terminal phase half life
Terminal phase half life, estimated using the equation [ln(2)/λz]
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics in Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- scPharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rene Myers, Ph.D., Study director, scPharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561442
- Sponsor's protocol ID
- scP-02-001
- Status last verified
- Apr 2017
- First submitted
- 24 Sep 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Three-way, Partially Blinded Crossover Study to Compare the Pharmacokinetics and Bioavailability of Ceftriaxone Administered as a 1 Gram Intravenous Infusion, a 1 Gram Subcutaneous Infusion and a 2 Gram Subcutaneous Infusion in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02561442
- Acronym / sponsor ID
- scP-02-001
- Conditions
- Pharmacokinetics in Healthy Adults
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- scPharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to assess the time above MIC (4 mg/mL), and the pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone administered as a constant IV infusion over 0.5 hours. In addition, the study will compare the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2 g ceftriaxone administered subcutaneously
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV ceftriaxone (0.5hr) 1 gm | Active comparator | Drug: ceftriaxoneceftriaxone for injection, (total dose = 1.0 g) administered IV over 30 minutes via infusion pump (Open Label) |
| subcutaneous ceftriaxone, (2hr), 1 gm | Experimental | Drug: ceftriaxoneceftriaxone for injection, (total dose = 1.0 g) administered subcutaneous over 2 hours (Blinded). |
| subcutaneous ceftriaxone, (2 hr), 2 gm | Experimental | Drug: ceftriaxoneceftriaxone for injection, (total dose = 2.0 g) administered subcutaneous over 2 hours (Blinded). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects between 18 and 65 years of age inclusive.
- Subjects must have body weight of 45.5 to 105 kg inclusive and body mass index (BMI) ≤34 kg/m2.
- Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (e.g., tubal ligation, hysterectomy) for at least 90 days, or agree, from the time of signing the informed consent or 14 days prior to Baseline until Follow-up, to use TWO (2) of the following forms of contraception: a IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, a sterile sexual partner, OR abstinence. For all females, a pregnancy test result must be negative at Screening and Baseline/Day 0
- Males agree from the time of Baseline/Day 0 until Follow-up, to use TWO (2) forms of contraception: ONE must be a male condom with spermicide; the second may be ONE of the following: his female partner uses either an IUD with spermicide, female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system, diaphragm with spermicide, cervical cap with spermicide, oral contraceptives; OR abstinence
Key exclusion criteria (16 listed)
- Evidence of or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurological, immunologic, nephrologic, endocrine, or psychiatric disease, or current clinically significant infection.
- History of chronic skin conditions requiring medical therapy.
- Clinically significant abnormalities at Screening or Baseline in safety laboratory tests.
- Corrected QT interval (QTc) greater than 450 msec for males and 470 msec for females as corrected by the Fridericia formula.
- Major surgery within 30 days prior to Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftriaxone | Drug | IV ceftriaxone (0.5hr) 1 gm, subcutaneous ceftriaxone, (2 hr), 2 gm, subcutaneous ceftriaxone, (2hr), 1 gm |
Primary outcome
Maximum Plasma Concentration
Time frame: 48 hours
Cmax, observed by inspection of individual study participant plasma concentration time plots.
Time of observed maximum plasma concentration
Time frame: 48 hours
Tmax, obtained directly from the observed concentration-time data
Area under the plasma concentration-time curve
Time frame: 48 hours
AUClast: AUC from time 0 to the last measureable non-zero concentration, calculated by a combination of linear and logarithmic trapezoidal methods
Area under the concentration time curve, extrapolated to infinity
Time frame: 48 hours
AUCinf: Area under the concentration time curve from time 0 extrapolated to infinity, calculated as AUClast + Clast/λz
Terminal phase elimination rate constant
Time frame: 48 hours
Terminal phase elimination rate constant, estimated by linear regression of logarithmically transformed concentration versus time data.
Terminal phase half life
Time frame: 48 hours
Terminal phase half life, estimated using the equation [ln(2)/λz]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene Myers, Ph.D. study director
scPharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ceftriaxone in people with Pharmacokinetics in Healthy Adults, run by scPharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (time frame: 48 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.