Chemotherapy Induced Peripheral Neuropathy (CIPN)Phase 1NCT03430999
SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing Calmangafodipir in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Egetis Therapeutics AB (publ) at 1 site in United States.
Trial summary
Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Calmangafodipir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 18 Dec 2017
- Phase
- Phase 1
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
- Non-smoker or not smoking for at least 12 months
- Be first generation Japanese (For Group 1 only), defined as:
- Born in Japan
- Has 2 Japanese biological parents and 4 Japanese biological grandparents
- Has lived outside of Japan for less than 5 years
- Has made no significant changes in lifestyle, including diet, since leaving Japan
Who cannot join
- Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- Has a history of drug or alcohol abuse
- Has previously received calmangafodipir or mangafodipir
- Welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects
Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.
- Being tested
- Calmangafodipir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalmangafodipirDrug
Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Japanese) Calmangafodipir | Experimental | Not described Receives: Drug: Calmangafodipir |
| Group 1 (Japanese) Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Group 2 (Caucasian) Calmangafodipir | Experimental | Not described Receives: Drug: Calmangafodipir |
| Group 2 (Caucasian) Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events
Subject incidence of treatment-emergent adverse events (TEAEs), which may include changes in laboratory safety tests, electrocardiograms (ECG), and vital signs.
Measured: From signing of informed consent through the last follow up visit (up to Day 10)
Secondary outcomes (5)
Cmax
Maximum plasma concentration during a dosing interval
Measured: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
tmax
Time to reach maximum plasma concentration
Measured: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
AUC(0-last)
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Measured: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Ae
Amount of manganese and zinc excreted into urine
Measured: 4 hours post-dose and 24 hours post-dose
Ae%
Percent of study drug manganese excreted into urine
Measured: 4 hours and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start7 Nov 2017
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egetis Therapeutics AB (publ)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430999
- Sponsor's protocol ID
- PP06466
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 13 Feb 2018
- 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 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUNCIST: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of Intravenous Administration of Calmangafodipir in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03430999
- Acronym / sponsor ID
- PP06466
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Egetis Therapeutics AB (publ)Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 13 Feb 2018 (actual)
- 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.
Randomized, double-bline, placebo-controlled, single dose study comparing the pharmacokinetics (PK) and safety of PP095-01 in Japanese and non-Asian (eg, Caucasian) subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Japanese) Calmangafodipir | Experimental | Drug: Calmangafodipir |
| Group 1 (Japanese) Placebo | Placebo comparator | Drug: Placebo |
| Group 2 (Caucasian) Calmangafodipir | Experimental | Drug: Calmangafodipir |
| Group 2 (Caucasian) Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic
- Non-smoker or not smoking for at least 12 months
- Be first generation Japanese (For Group 1 only), defined as:
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for hematology, clinical chemistry, urinalysis, physical exam, vital signs, or electrocardiogram at screening
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- Has a history of drug or alcohol abuse
- Has previously received calmangafodipir or mangafodipir
- Welders, mine workers, or other workers in occupations (current or past) where high manganese exposure is likely
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 |
|---|---|---|
| CalmangafodipirSingle ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg | Drug | Group 1 (Japanese) Calmangafodipir, Group 2 (Caucasian) Calmangafodipir |
| PlaceboPlacebo | Drug | Group 1 (Japanese) Placebo, Group 2 (Caucasian) Placebo |
Primary outcome
Number of treatment-emergent adverse events
Time frame: From signing of informed consent through the last follow up visit (up to Day 10)
Subject incidence of treatment-emergent adverse events (TEAEs), which may include changes in laboratory safety tests, electrocardiograms (ECG), and vital signs.
5 secondary outcomes
Cmax
Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
tmax
Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
AUC(0-last)
Time frame: predose and 1 min, 15 min, 30 min, 1 hour, 4 hours, and 8 hours postdose
Ae
Time frame: 4 hours post-dose and 24 hours post-dose
Ae%
Time frame: 4 hours and 24 hours post-dose
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 13 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calmangafodipir in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Egetis Therapeutics AB (publ) at 1 site in United States.
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 8 inclusion and 5 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of treatment-emergent adverse events (time frame: From signing of informed consent through the last follow up visit (up to Day 10)). 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 13 Feb 2018.