EFFECT OF ADV7103 ON GASTRIC PHPhase 1B06NCT07446881
A Phase 1 Study, to Evaluate the Effect of ADV7103 on Gastric pH Under Fed and Fasting Conditions in Adult Healthy Participants.
A Phase 1 study testing ADV7103 in people with EFFECT OF ADV7103 ON GASTRIC PH and Distal Renal Tublular Acidosis, run by Advicenne Pharma at 1 site in France.
Trial summary
This was a Phase 1, single-center, randomized, controlled, Latin-square, open-label study to evaluate the effect of ADV7103 on the gastric pH, after administering a single oral dose of ADV7103 in healthy adult participants under fasting and fed conditions Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- EFFECT OF ADV7103 ON GASTRIC PH, Distal Renal Tublular Acidosis
- What is being tested?
- ADV7103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2025to 15 Mar 2025
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, who were aged 18-45 years (inclusive) on the day of signing the informed consent form (ICF).
- 4. Had a body weight between 50.0-100.0 kg (inclusive) at screening and D-1. 5. Had a body mass index (BMI) between 18.0-30.0 kg/m2 (inclusive) at screening and D-1.
- Participants had vital signs results within normal ranges at screening and D-1. If outside normal ranges, the values were considered by the Investigator without clinically significant abnormal findings. 7. Had physical examination results without clinically significant abnormal findings confirmed by the Investigator at screening and D-1. 8. Had clinical laboratory test results (hematology, coagulation, blood chemistry and urinalysis) within normal ranges at screening. If outside of normal ranges, the values were considered by the Investigator as not clinically significant, without abnormal findings.
- 9. Had 12-lead ECG results without clinically significant abnormal findings confirmed by the Investigator at screening.
- Female participants who were not pregnant confirmed by beta-human chorionic gonadotropin (β-HCG) or nursing at screening and D-1, or who were not planning to become pregnant during study period.
- 11. Female participants of non-childbearing potential, defined as one of the following:
Show all 16Show fewer
- At least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., appropriate age) and follicle-stimulating hormone (FSH) in the range for menopausal female confirmed by blood test according to current local standards at screening, except if treated with hormone replacement therapy (HRT]).
- Those with history of hysterectomy or surgical removal of both ovaries or bilateral tubal ligation performed at least 90 days prior to screening.
- 12. Female participants of childbearing potential (WOCBP) agreed to use an adequate and highly effective method of contraception (according to Clinical Trials Coordination Group [CTCG] recommendations) starting at screening and throughout the entire study: a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the dosing (D1) and use of condom for the male partner.
- Progestogen-only hormonal contraception associated with inhibition of ovulation, started at least 4 weeks prior to the dosing (D1) and use of condom for the male partner.
- Intrauterine device (IUD) placed at least 4 weeks prior to the dosing (D1), and use of condom for the male partner.
- Intrauterine hormone-releasing system (IUS) placed at least 4 weeks prior to the dosing (D1), and use of condom for the male partner.
- Simultaneous use of a diaphragm or cervical cap with intravaginally applied spermicide and, for the male partner, a male condom. f) Sterile male partner, i.e., vasectomized since at least 3 months before inclusion.
- Sexual abstinence[4] (when in line with the preferred and usual participant's lifestyle). Note: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. 13. Male participants were either surgically sterile (> 90 days since vasectomy), or abstinent as a usual practice, or if engaged in sexual relations with a WOCBP, the participant and his partner were either surgically sterile or used an acceptable, highly effective contraceptive method according to CTCG recommendations starting at screening and throughout the entire study.
- 14. Male participants agreed to abstain from sperm donation starting at screening and throughout the trial. Regulations 15. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- 16. Was competent in speaking, writing, and comprehending the local language(s) where the study is conducted.
Who cannot join
- Had a history of and/or current clinically significant, determined by the Investigator, gastrointestinal, renal, hepatic, cardiovascular, hematological, respiratory, neurologic, metabolic, psychiatric, infectious disorder, drug or alcohol abuse, or allergic disease, hypersensitivity, or allergic reactions excluding mild asymptomatic seasonal allergies (either spontaneous or following drug administration).
- 2. Had a history of malignancy (including lymphoma, leukemia, and skin cancer) unless remission at least 10 years prior to screening.
- 3. Had a history of metabolic alkalosis or hyperkalemia. 4. Had urinary infection. 5. Had a history of difficult access to the oral administration route and/or conditions that could have hampered compliance and/or absorption of the IMPs, and/or the use and/or the proper functioning of the pH probe (e.g., gastroesophageal reflux, gastrectomy, bariatric surgery).
- 6. Had a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
- 7. Had surgery (including invasive dental treatment or dental surgery) within one month or considered clinically significant by the Investigator, prior to D1, and/or planned to have surgery over the course of the study.
- 8. Had a history and/or current presence of an illness within 14 days prior to D1 that was categorized as clinically significant by the Investigator. Had history or presence of regular use of recreational drugs within 1 year before screening. 10. Donated blood or had blood loss (i.e., > 450 mL) within 1 month before screening.
Show all 13Show fewer
- 11. Had known allergies, hypersensitivity or intolerance to IMP, or excipients present in drug product.
- Physical and Laboratory Findings 12. Individualized estimated glomerular filtration rate (eGFR): [(standard CKD-EPI÷1.73)×BSA] <90 mL/min. at screening. 13. Had a positive pregnancy test for female participants. 14. Had a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab) at screening.
- 15. Had positive findings of urine drug screen (methadone, barbiturates, morphine, amphetamines, methamphetamines, opiates, cannabinoids, cocaine, benzodiazepines, tricyclic antidepressants (TCA), 3,4-methylenedioxy-methamphetamine [MDMA; ecstasy]) at screening or D-1.
- 16. Had a positive alcohol breath test result at screening or D-1. Lifestyle Restrictions 17. Consumed any xanthine-containing products (e.g., coffee, tea, chocolate, or Coca-Cola like drinks) more than 6 cups per day (or equivalent), or alcoholic beverages within 24h before study D1.
- 18. Had regular consumption of alcoholic beverages that exceeded 21 units per week (1 unit = 12 g of pure alcohol) for males and 14 units per week for females.
- 19. Consumed nicotine daily (i.e., ≥10 cigarettes, vaping or chewing tobacco, nicotine patch or gum), or was unable to stop, from screening to the end of the hospitalization period or had substantial changes in nicotine consumption in the 4 weeks prior to screening. Prior/Concurrent Clinical Study Experience 20. Participants who had participated in another clinical study and were in the exclusion period or were participating in or intended to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
- Prohibited Treatments 21. Used any prescription drugs within 2 weeks prior to first dosing, or over-the-counter (OTC) medication (vitamins, herbal supplements, St. John's wort, dietary supplements) within 5 days prior to first dosing (14 days for compounds with a half-life longer than 24h). Paracetamol (acetaminophen) was acceptable, if allowed by the Investigator, up to 2 intakes of 1000 mg per day. Prescribed hormonal contraception for WOCBP and HRT for post-menopausal women was also acceptable. Other Exclusions 22. Participants who, in the opinion of the Investigator, were not likely to complete the study for whatever reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Controlled, Latin-square, Open-label Study, to Evaluate the Effect of ADV7103 on Gastric pH Under Fed and Fasting Conditions in Adult Healthy Participants
This was a Phase 1, single-center, randomized, controlled, Latin-square, open-label study to evaluate the effect of ADV7103 on the gastric pH, after administering a single oral dose of ADV7103 in healthy adult participants under fasting and fed conditions
- Being tested
- ADV7103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADV7103Drug
Also called Sibnayal
EFFECT ON GASTRIC PH
| Study group | Role | What they receive |
|---|---|---|
| ADV7103 | Experimental | open label single group phase 1 Receives: Drug: ADV7103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of a single dose of ADV7103 on gastric pH under fasting and fed conditions in adult healthy participants.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start25 Feb 2025
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EFFECT OF ADV7103 ON GASTRIC PHStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study comprised: * A screening period from Day (D)-28 to D-2. * One hospitalization period from D-1 to D4. * A series of pre-dose assessments on hospitalization at D-1 and before the beginning of each treatment sequence: * Four consecutive study periods (SPs), according to a (4x4) Williams Latin-square cross-over design. * A wash-out period between the initiation of 2 consecutive SPs (T0) of at least 20 hours (h). * Discharge on D4, once the pH recording of last SP was complete. * An end-of-study (EOS) evaluation was done at D4.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advicenne Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian J Hapner, MD, PhD, Study director, Advicenne S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446881
- Sponsor's protocol ID
- B06CS
- Acronym
- B06
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 10 Mar 2026
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Controlled, Latin-square, Open-label Study, to Evaluate the Effect of ADV7103 on Gastric pH Under Fed and Fasting Conditions in Adult Healthy Participants
- ClinicalTrials.gov ID
- NCT07446881
- Acronym / sponsor ID
- B06 / B06CS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Advicenne PharmaIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 3 Mar 2026 (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.
This was a Phase 1, single-center, randomized, controlled, Latin-square, open-label study to evaluate the effect of ADV7103 on the gastric pH, after administering a single oral dose of ADV7103 in healthy adult participants under fasting and fed conditions
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study comprised: * A screening period from Day (D)-28 to D-2. * One hospitalization period from D-1 to D4. * A series of pre-dose assessments on hospitalization at D-1 and before the beginning of each treatment sequence: * Four consecutive study periods (SPs), according to a (4x4) Williams Latin-square cross-over design. * A wash-out period between the initiation of 2 consecutive SPs (T0) of at least 20 hours (h). * Discharge on D4, once the pH recording of last SP was complete. * An end-of-study (EOS) evaluation was done at D4.
| Arm | Type | Receives |
|---|---|---|
| ADV7103 | Experimental | Drug: ADV7103open label single group phase 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Healthy male or female, who were aged 18-45 years (inclusive) on the day of signing the informed consent form (ICF).
- 4. Had a body weight between 50.0-100.0 kg (inclusive) at screening and D-1. 5. Had a body mass index (BMI) between 18.0-30.0 kg/m2 (inclusive) at screening and D-1.
- Participants had vital signs results within normal ranges at screening and D-1. If outside normal ranges, the values were considered by the Investigator without clinically significant abnormal findings. 7. Had physical examination results without clinically significant abnormal findings confirmed by the Investigator at screening and D-1. 8. Had clinical laboratory test results (hematology, coagulation, blood chemistry and urinalysis) within normal ranges at screening. If outside of normal ranges, the values were considered by the Investigator as not clinically significant, without abnormal findings.
- 9. Had 12-lead ECG results without clinically significant abnormal findings confirmed by the Investigator at screening.
- Female participants who were not pregnant confirmed by beta-human chorionic gonadotropin (β-HCG) or nursing at screening and D-1, or who were not planning to become pregnant during study period.
Key exclusion criteria (13 listed)
- Had a history of and/or current clinically significant, determined by the Investigator, gastrointestinal, renal, hepatic, cardiovascular, hematological, respiratory, neurologic, metabolic, psychiatric, infectious disorder, drug or alcohol abuse, or allergic disease, hypersensitivity, or allergic reactions excluding mild asymptomatic seasonal allergies (either spontaneous or following drug administration).
- 2. Had a history of malignancy (including lymphoma, leukemia, and skin cancer) unless remission at least 10 years prior to screening.
- 3. Had a history of metabolic alkalosis or hyperkalemia. 4. Had urinary infection. 5. Had a history of difficult access to the oral administration route and/or conditions that could have hampered compliance and/or absorption of the IMPs, and/or the use and/or the proper functioning of the pH probe (e.g., gastroesophageal reflux, gastrectomy, bariatric surgery).
- 6. Had a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
- 7. Had surgery (including invasive dental treatment or dental surgery) within one month or considered clinically significant by the Investigator, prior to D1, and/or planned to have surgery over the course of the study.
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 |
|---|---|---|
| ADV7103Also: SibnayalEFFECT ON GASTRIC PH | Drug | ADV7103 |
Primary outcome
The effect of a single dose of ADV7103 on gastric pH under fasting and fed conditions in adult healthy participants.
Time frame: 4 days
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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.
Adrian J Hapner, MD, PhD study director
Advicenne S.A.
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 ADV7103 in people with EFFECT OF ADV7103 ON GASTRIC PH and Distal Renal Tublular Acidosis, run by Advicenne Pharma at 1 site in France.
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 13 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 10 Mar 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 France. 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?
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?
The effect of a single dose of ADV7103 on gastric pH under fasting and fed conditions in adult healthy participants. (time frame: 4 days). 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 10 Mar 2026.