Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
- Summary
- This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of KSP-1007. Repeated escalating doses of KSP-1007 will be co-administered with meropenem (Part 3) and single, ascending doses of KSP-1007 will be administered alone in healthy Japanese subjects (Part 4)
- Short title
- Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2022-10-01
- First posted
- 2022-02-07
- Registry last updated
- 2022-10-27
- Primary completion date
- 2022-10-01
- Start date
- 2022-01-12
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sumitovant Biopharma, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05226923
- ClinicalTrials.gov ID
- NCT05226923
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Incidence of adverse events assessed by subject .
Timeframe: up to Day 14
Incidence of adverse events
Peak plasma concentration of KSP-1007
Timeframe: Up to 5 days after dosing
The plasma concentration of KSP-1007 will be measured over time, and the peak plasma concentration, or Cmax, of KSP-1007 will be determined
Plasma concentration of KSP-1007 versus time curve
Timeframe: Up to 5 days after dosing
The plasma concentration of KSP-1007 will be measured over time and the area under the curve, or AUC, of KSP-1007 will be determined
Cumulative amount of KSP-1007 excreted in urine over time
Timeframe: Up to 5 days after start of dosing
Total amount of unchanged drug excreted in urine over a dosing interval
Renal clearance of KSP-1007 in urine over time
Timeframe: Up to 5 days after start of dosing
Renal clearance in urine. Urine was collected up to 5 days after dosing.
Peak plasma concentration of meropenem
Timeframe: Up to 5 days after start of dosing
The plasma concentration of meropenem will be measured over time, and the peak plasma concentration, or Cmax, of meropenem will be determined
Plasma concentration versus time curve of meropenem
Timeframe: Up to 5 days after start of dosing
The plasma concentration of meropenem will be measured over time and the area under the curve, or AUC, of meropenem will be determined
Cumulative amount of meropenem excreted in urine over time
Timeframe: Up to 5 days after start of dosing
Total amount of unchanged drug excreted in urine over a dosing interval.
Renal clearance of meropenem in urine over time
Timeframe: Up to 5 days after start of dosing
Renal clearance in urine. Urine was collected up to 5 days after dosing.
ECG QTcF interval
Timeframe: 24 hours after start of dosing
Change from baseline QTcF interval
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- Healthy male or female subjects 18 to 55 years of age, inclusive
- Females that engage in heterosexual activity must agree to use a highly selective birth control (BC) method (< 1% failure rate per year) throughout the study, or have a documented reproductive status of non-childbearing based on medical history, or is postmenopausal
- Males that engage in heterosexual activity that has the risk of pregnancy must agree to use effective BC and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication
- Body mass index (BMI) 2: 18 kg/m2 and :s 32 kg/m2
- History of Gilbert's Syndrome
- History of severe allergic reactions to β-lactams or β-lactamase inhibitors or a history allergic reactions to multiple medications.
- Pregnant female, determined by positive serum or urine human chorionic gonadotropin pregnancy test at Screening, or prior to dosing
- Lactating female
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of > 499 mL within 56 days prior to Day 1
- Participation in a study with an investigational drug or device study with last dose of investigational drug within 30 days (90 days if the study involved a biologic, cellular, or vaccine product) or 5 half-lives, whichever is longer, before study treatment administration
- Subjects with abnormal hepatic and/or renal function, that could interfere with the metabolism, and/or excretion of the study treatments
- Abnormal blood pressure, either low (defined as < 90 mmHg systolic and/ or < 45 mmHg diastolic) or high (defined as > 140 mmHg systolic and/ or > 90 mmHg diastolic) at Screening
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV at Screening. Subjects who test positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) also will be ineligible. Evidence of prior HBV vaccination (positive hepatitis B surface antibody [HBsAb)) is not exclusionary.
- Subjects unable to abstain from alcohol for 48 hours prior to admission through to completion of the Follow-up visit
- PRA Health SciencesLenexa, United States
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Bacterial infectious disease Primary condition