Healthy VolunteersEarly Phase 1NCT03105375
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Human: A Single/Multiple Ascending Dose Study
A Early Phase 1 study testing Single ascending dose of X842, Multiple ascending dose of X842 and Losec in people with Healthy Volunteers, run by Cinclus Pharma Holding AB at 1 site in Sweden.
Trial summary
The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data following single ascending and multiple ascending doses of X842 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Single ascending dose of X842, Multiple ascending dose of X842 and Losec
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSweden
- Study dates
- 21 Feb 2017to 12 Oct 2017
- Phase
- Early 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give written informed consent for participation in the study.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight at least 50 kg and no more than 100 kg at screening.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Male subjects must be willing to use condom and if they have a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until three months after dosing of the IMP.
- Female subjects must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and estradiol <200 pmol/L is confirmatory]).
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Present clinically significant psychiatric diagnosis, at discretion of the Investigator.
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of investigational medical product.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
- History of any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs. The investigator is to be guided by evidence of any of the following: history of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, bowel resection or Transjugular Intrahepatic Portosystemic Shunt (TIPS).
- History or presence of diagnosed and long-term treatment for GERD.
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- Likelihood of having a gastric pH>2 due to for example known autoimmune gastritis or known Helicobacter pylori gastritis.
- Known severe atrophic gastritis.
- Vitamin B-12 deficiency and/or chronic Vitamin B-12 substitution.
- Known malabsorption.
- Any planned major surgery within the duration of the study.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- After 10 minutes of supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic BP 90 - 140 mm Hg
- Diastolic BP 50 - 90 mm Hg
- Heart rate (HR) 45-90 beats per minute
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to X842 or omeprazole.
- Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins and minerals within two weeks prior to the (first) administration of IMP, except occasional intake of paracetamol (maximum 2 000 mg/day; and not exceeding 6 000 mg/week), at the discretion of the Investigator and nasal decongestants without cortisone or antihistamine for a maximum of 10 days, at the discretion of the Investigator.
- Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. Subjects consented and screened but not dosed in previous phase I studies are not excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
- Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.
- Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse.
- Intake of xanthine and/or taurine containing energy drinks within two days prior to first day of IMP administration.
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Healthy Subjects
The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data following single ascending and multiple ascending doses of X842 in healthy subjects.
Read the detailed description
This is a single-centre, open label, first-in-human study with the primary objective to evaluate safety and tolerability of X842 after administration of single and multiple oral ascending doses to healthy male and female subjects. The study comprises a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part including an open-label multiple dose cohort administered active comparator (omeprazole). Four subjects will be included in each of the SAD and MAD cohorts.
- Conditions
- Healthy Volunteers
- Being tested
- Single ascending dose of X842, Multiple ascending dose of X842, Losec
- Keywords
- Potassium competitive acid blocker, X842, Gastroesophageal reflux disease, Esophagitis, Intragastric pH, Acid inhibition
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single ascending dose of X842Drug
Also called X842
Each subject in a the same cohort will be assigned to the same single dose of X842. The subjects in the subsequent cohort will be assigned to a single dose of X842 based on safety and efficacy data generated from the previous cohort.
Multiple ascending dose of X842Drug
Also called X842
Each subject in a the same cohort will be assigned to the same dose of X842 once daily for five days. The subjects in the subsequent cohort will be assigned to same dose of X842 once daily for five days based on safety and efficacy data generated from the previous cohort.
LosecDrug
Also called omeprazole
Each subject in one cohort will be assigned to a standard dose of omeprazole once daily for five days.
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose of X842 | Experimental | Single ascending oral dose of X842 administered to subjects in cohorts. Cohorts are administered in sequence. Receives: Drug: Single ascending dose of X842 |
| Multiple ascending dose of X842 | Experimental | Multiple ascending oral dose of X842 administered to subjects in cohorts. Cohorts are administered in sequence. Receives: Drug: Multiple ascending dose of X842 |
| Losec | Active comparator | Standard oral dose of omeprazole administered to subjects in one cohort. Receives: Drug: Losec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination after single and multiple doses of X842. Summary statistics will be applied.
Safety and tolerability will be assessed by occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination. The adverse event assessment will follow the recommendations and grading system of Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Summary statistics will be applied.
Measured: Five weeks
Secondary outcomes (3)
Measurement of the PK profile (Cmax)
To assess the Maximum Plasma Concentration (Cmax)
Measured: Up to 48 hours after dosing
Measurement of the PK profile (t1/2)
To assess the plasma half life (t1/2) of drug
Measured: Up to 48 hours after dosing
Measurement of the PD profile (intragastric pH)
To assess and characterize the PD profile with measurements of intragastric pH
Measured: Up to 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start21 Feb 2017
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- SAD and MAD study
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinclus Pharma Holding AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cornelia Lif-Tiberg, MD, Principal investigator, CTC Clinical Trial Consultants AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105375
- Sponsor's protocol ID
- CX842A2101
- Status last verified
- Nov 2017
- First submitted
- 1 Mar 2017
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersson K, Carlsson E. Potassium-competitive acid blockade: a new therapeutic strategy in acid-related diseases. Pharmacol Ther. 2005 Dec;108(3):294-307. doi: 10.1016/j.pharmthera.2005.05.005. Epub 2005 Jul 5.
PubMed 16000224Hunt RH, Scarpignato C. Potassium-Competitive Acid Blockers (P-CABs): Are They Finally Ready for Prime Time in Acid-Related Disease? Clin Transl Gastroenterol. 2015 Oct 29;6(10):e119. doi: 10.1038/ctg.2015.39.
PubMed 26513137
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03105375
- Acronym / sponsor ID
- CX842A2101
- Conditions
- Healthy Volunteers
- Keywords
- Potassium competitive acid blocker, X842, Gastroesophageal reflux disease, Esophagitis, Intragastric pH, Acid inhibition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cinclus Pharma Holding ABIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 7 Apr 2017 (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.
The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data following single ascending and multiple ascending doses of X842 in healthy subjects.
Detailed description
This is a single-centre, open label, first-in-human study with the primary objective to evaluate safety and tolerability of X842 after administration of single and multiple oral ascending doses to healthy male and female subjects. The study comprises a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part including an open-label multiple dose cohort administered active comparator (omeprazole). Four subjects will be included in each of the SAD and MAD cohorts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- SAD and MAD study
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose of X842 | Experimental | Drug: Single ascending dose of X842Single ascending oral dose of X842 administered to subjects in cohorts. Cohorts are administered in sequence. |
| Multiple ascending dose of X842 | Experimental | Drug: Multiple ascending dose of X842Multiple ascending oral dose of X842 administered to subjects in cohorts. Cohorts are administered in sequence. |
| Losec | Active comparator | Drug: LosecStandard oral dose of omeprazole administered to subjects in one cohort. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent for participation in the study.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight at least 50 kg and no more than 100 kg at screening.
- Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
- Male subjects must be willing to use condom and if they have a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until three months after dosing of the IMP.
- Female subjects must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and estradiol <200 pmol/L is confirmatory]).
Key exclusion criteria (26 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Present clinically significant psychiatric diagnosis, at discretion of the Investigator.
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of investigational medical product.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
- History of any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs. The investigator is to be guided by evidence of any of the following: history of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, bowel resection or Transjugular Intrahepatic Portosystemic Shunt (TIPS).
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 |
|---|---|---|
| Single ascending dose of X842Also: X842Each subject in a the same cohort will be assigned to the same single dose of X842. The subjects in the subsequent cohort will be assigned to a single dose of X842 based on safety and efficacy data generated from the previous cohort. | Drug | Single ascending dose of X842 |
| Multiple ascending dose of X842Also: X842Each subject in a the same cohort will be assigned to the same dose of X842 once daily for five days. The subjects in the subsequent cohort will be assigned to same dose of X842 once daily for five days based on safety and efficacy data generated from the previous cohort. | Drug | Multiple ascending dose of X842 |
| LosecAlso: omeprazoleEach subject in one cohort will be assigned to a standard dose of omeprazole once daily for five days. | Drug | Losec |
Primary outcome
Occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination after single and multiple doses of X842. Summary statistics will be applied.
Time frame: Five weeks
Safety and tolerability will be assessed by occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination. The adverse event assessment will follow the recommendations and grading system of Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Summary statistics will be applied.
3 secondary outcomes
Measurement of the PK profile (Cmax)
Time frame: Up to 48 hours after dosing
Measurement of the PK profile (t1/2)
Time frame: Up to 48 hours after dosing
Measurement of the PD profile (intragastric pH)
Time frame: Up to 24 hours after dosing
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 17 Jun 2026.
- Background: PubMed 16000224Andersson K, Carlsson E. Potassium-competitive acid blockade: a new therapeutic strategy in acid-related diseases. Pharmacol Ther. 2005 Dec;108(3):294-307. doi: 10.1016/j.pharmthera.2005.05.005. Epub 2005 Jul 5.
- Background: PubMed 26513137Hunt RH, Scarpignato C. Potassium-Competitive Acid Blockers (P-CABs): Are They Finally Ready for Prime Time in Acid-Related Disease? Clin Transl Gastroenterol. 2015 Oct 29;6(10):e119. doi: 10.1038/ctg.2015.39.
- 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.
Cornelia Lif-Tiberg, MD principal investigator
CTC Clinical Trial Consultants AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Single ascending dose of X842, Multiple ascending dose of X842 and Losec in people with Healthy Volunteers, run by Cinclus Pharma Holding AB at 1 site in Sweden.
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 5 inclusion and 26 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 17 Jun 2026. 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 Sweden. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination after single and multiple doses of X842. Summary statistics will be applied. (time frame: Five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105375, which also lists 2 linked publications.
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 17 Jun 2026.