A Phase 2 interventional study of Encaleret in Autosomal Dominant Hypocalcemia (ADH) and Autosomal Dominant Hypocalcemia Type 1 (ADH1), sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company (part of BridgeBio) · Phase 2, Interventional, and Treatment
The primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
Calcilytix Therapeutics, Inc., a BridgeBio company is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Period 1: Participants will receive an ascending dose of encaleret once daily for the first 3 days. Participants will then receive an individualized dose of encaleret twice daily for 2 days. Period 2: Participants will receive encaleret twice daily for 5 days at a single dose level based on responses from Period 1. Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks. Long-Term Extension (LTE): At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years.
Drug: Encaleret
Participants will directly be enrolled into Period 2, and receive encaleret twice daily at a dose based on data and responses from Cohort 1 Period 1. Period 2: Participants will receive encaleret twice daily for 5 days. Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks. LTE: At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years.
Drug: Encaleret
Tablets administered orally
Also known as: CLTX-305
Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Treatment-emergence was defined as any AE(s) regardless of relationship to investigational medicinal product (IMP), that had an onset or worsened in severity on or after the first dose of IMP.
Time frame: Day 1 up to 16 months
Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa)
Time frame: Baseline, Week 24
Period 3: Rate of Urinary Calcium Excretion
Time frame: Week 24
Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood
Blood samples were taken for analysis of iPTH concentrations. iPTH concentrations were analyzed via an electrochemiluminescence immunoassay.
Time frame: 15 minutes pre-dose on Day 5 of Periods 1 and 2 (Periods were 5 days)
Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret
Time frame: Periods 1 and 2: Day 5 (Periods were 5 days)
Periods 1, 2 and 3: Maximum Plasma Concentration (Cmax) of Encaleret
Time frame: Periods 1 and 2: Day 5, Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Time to Maximum Plasma Concentration (Tmax) of Encaleret
Time frame: Periods 1 and 2: Day 5; Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 2 and 3: Change From Baseline in Blood Calcium Concentration (cCa)
Data values presented are for the change from baseline for the average values at the specified timepoints/visits.
Time frame: Period 2: Baseline, Day 5 (Period was 5 days), Period 3: Baseline, Week 24 (Period was 24 weeks)
Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion
Fractional Excretion of Calcium was derived as (Urine Calcium at the interval considered \* Serum Creatinine at the end of the interval considered)/(Serum Calcium at the end of the interval considered \* Urine Creatinine at the interval considered) and is presented as percentage.
Time frame: Period 3: Week 24, 15 minutes pre-dose (Period was 24 weeks)
Periods 1, 2 and 3: Urinary Calcium Clearance as Assessed by 24-Hour Total Excretion
Time frame: Periods 1 and 2: Day 5; Period 3, Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Renal Function as Assessed by Estimated Glomerular Filtration Rate (eGFR)
eGFR was calculated using Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula (mL/min/1.73m\^2) = 141 x min (SCr/K, 1)\^α x max(SCR /K,1)-1.209 x 0.993Age x 1.018 \[if female\] x 1.159 \[if Black\], where SCr is the serum creatinine (mg/dL), K = 0.7 for female and 0.9 for males, α is -0.329 for female and -0.411 for males.
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose) (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Serum Levels of 1,25-(OH)2 Vitamin D
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Magnesium, Phosphorus, and Creatinine Levels as Assessed by Blood Sample Examinations
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Creatinine, Phosphorus, Magnesium, and Citrate Total Excretion Levels as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: pH as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-24 hours post-dose), Period 3: Week 24: (0-24 hours post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Potassium and Sodium Total Excretion Levels as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for periods 1 and 2; 24 weeks for period 3)
Periods 1, 2 and 3: Cyclic Adenosine Monophosphate (cAMP) Total Excretion Levels as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-4h post-dose), Period 3: Week 24 (0-4h post dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Bone Resorption Markers as Assessed by Collagen Cross-Linked C-Telopeptide (CTx)
Blood samples were taken for analysis of bone resorption markers (CTx).
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Bone Formation Markers as Assessed by Blood Procollagen Type 1 N-Propeptide (P1NP)
Blood samples were taken for analysis of bone formation markers (P1NP).
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
| Milestone | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Started | 6 | 0 | 0 |
| Received at least one dose of study treatment | 6 | 0 | 0 |
| Completed | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Started | 0 | 13 | 0 |
| Received at least one dose of study treatment | 0 | 13 | 0 |
| Completed | 0 | 13 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Started | 0 | 0 | 13 |
| Received at least one dose of study treatment | 0 | 0 | 13 |
| Completed | 0 | 0 | 13 |
| Not completed | 0 | 0 | 0 |
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Treatment-emergence was defined as any AE(s) regardless of relationship to investigational medicinal product (IMP), that had an onset or worsened in severity on or after the first dose of IMP.
| Participants | Period 1: Encaleret | Periods 2 and 3: Encaleret |
|---|---|---|
| Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 5 | 13 |
| milligrams (mg)/deciliter (dL) | Period 3: Encaleret |
|---|---|
| Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa) | 1.9 ± 0.48 |
| mg/24hour (hr) | Period 3: Encaleret |
|---|---|
| Period 3: Rate of Urinary Calcium Excretion | 202 ± 83 |
Blood samples were taken for analysis of iPTH concentrations. iPTH concentrations were analyzed via an electrochemiluminescence immunoassay.
| Picograms (pg)/milliliter (mL) | Period 1: Encaleret | Period 2: Encaleret |
|---|---|---|
| Period 1: Day 5 (180 mg) | 43.8 ± 34.06 | — |
| Period 2: Day 5 | — | 20.6 ± 15.87 |
| hour (hr)*nanogram (ng)/milliliter (mL) | Period 1: Encaleret | Period 2: Encaleret |
|---|---|---|
| Period 1: Day 5 AM 180mg | 11283.7 ± 3556.12 | — |
| Period 1: Day 5 PM 180 mg | 13127.7 ± 2992.61 | — |
| Period 1: Day 5 PM 120 mg | 12417.0 ± NA | — |
| Period 2: Day 5 PM 10mg | — | 623.7 ± NA |
| nanograms (ng)/milliliter (mL) | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM 180mg | 2593.3 ± 655.89 | — | — |
| Period 1: Day 5 PM 180 mg | 1834.0 ± 470.46 | — | — |
| Period 1: Day 5 PM 120 mg | 1890.0 ± NA | — | — |
| Period 2: Day 5AM 10 mg | — | 102.0 ± NA | — |
| Period 2: Day 5AM 30 mg | — | 223.6 ± 169.94 | — |
| Period 2: Day 5AM 60 mg | — | 496.0 ± NA | — |
| Period 2: Day 5AM 90 mg | — | 1041.0 ± 303.40 | — |
| Period 2: Day 5AM 120 mg | — | 1720.0 ± NA | — |
| Period 2: Day 5AM 150 mg | — | 1560.0 ± NA | — |
| Period 2: Day 5AM 180 mg | — | 1956.7 ± 748.09 | — |
| Period 2: Day 5PM 10 mg | — | 134.3 ± 34.53 | — |
| Period 2: Day 5PM 30 mg | — | 226.0 ± NA | — |
| Period 2: Day 5PM 60 mg | — | 373.0 ± NA | — |
| Period 2: Day 5PM 90 mg | — | 822.3 ± 73.93 | — |
| Period 2: Day 5PM 120 mg | — | 1670.0 ± NA | — |
| Period 2: Day 5PM 150 mg | — | 1590.0 ± NA | — |
| Period 2: Day 5PM 180 mg | — | 2203.3 ± 254.23 | — |
| Period 3: Week 24 5 mg | — | — | 44.4 ± NA |
| Period 3: Week 24 10 mg | — | — | 58.6 ± NA |
| Period 3: Week 24 20 mg | — | — | 200.5 ± 50.20 |
| Period 3: Week 24 30 mg | — | — | 466.0 ± NA |
| Period 3: Week 24 60 mg | — | — | 403.0 ± NA |
| Period 3: Week 24 70 mg | — | — | 472.0 ± NA |
| Period 3: Week 24 80 mg | — | — | 872.0 ± NA |
| Period 3: Week 24 120 mg | — | — | 1090.0 ± NA |
| Period 3: Week 24 150 mg | — | — | 1110.0 ± NA |
| Period 3: Week 24 180 mg | — | — | 2125.0 ± 21.21 |
| Period 3: Week 24 190 mg | — | — | 2080.0 ± NA |
| hour | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM 180mg | 1.1 (1.0 to 3.0) | — | — |
| Period 1: Day 5 PM 180 mg | 1.5 (1.5 to 3.0) | — | — |
| Period 1: Day 5 PM 120 mg | 2.0 (2.0 to 2.0) | — | — |
| Period 2: Day 5AM 10 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5AM 30 mg | — | 4.0 (1.5 to 4.0) | — |
| Period 2: Day 5AM 60 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5AM 90 mg | — | 1.5 (1.5 to 4.0) | — |
| Period 2: Day 5AM 120 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5AM 150 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5AM 180 mg | — | 1.5 (1.5 to 4.0) | — |
| Period 2: Day 5PM 10 mg | — | 1.4 (0.5 to 1.5) | — |
| Period 2: Day 5PM 30 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5PM 60 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5PM 90 mg | — | 1.5 (0.5 to 1.5) | — |
| Period 2: Day 5PM 120 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5PM 150 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 2: Day 5PM 180 mg | — | 1.5 (1.5 to 1.5) | — |
| Period 3: Week 24 5 mg | — | — | 2.0 (2.0 to 2.0) |
| Period 3: Week 24 10 mg | — | — | 2.0 (2.0 to 2.0) |
| Period 3: Week 24 20 mg | — | — | 2.0 (2.0 to 2.0) |
| Period 3: Week 24 30 mg | — | — | 0.5 (0.5 to 0.5) |
| Period 3: Week 24 60 mg | — | — | 2.0 (2.0 to 2.0) |
| Period 3: Week 24 70 mg | — | — | 4.0 (4.0 to 4.0) |
| Period 3: Week 24 80 mg | — | — | 0.5 (0.5 to 0.5) |
| Period 3: Week 24 120 mg | — | — | 2.0 (2.0 to 2.0) |
| Period 3: Week 24 150 mg | — | — | 4.0 (4.0 to 4.0) |
| Period 3: Week 24 180 mg | — | — | 2.0 (2.0 to 2.1) |
| Period 3: Week 24 190 mg | — | — | 2.0 (2.0 to 2.0) |
Data values presented are for the change from baseline for the average values at the specified timepoints/visits.
| milligram (mg)/ deciliter (dL) | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|
| Period 2: Day 5 | 1.5 ± 0.60 | — |
| Period 3: Week 24 | — | 1.9 ± 0.48 |
Fractional Excretion of Calcium was derived as (Urine Calcium at the interval considered \* Serum Creatinine at the end of the interval considered)/(Serum Calcium at the end of the interval considered \* Urine Creatinine at the interval considered) and is presented as percentage.
| percentage | Period 3: Encaleret |
|---|---|
| Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion | 0.016 ± 0.004 |
| mg/24hr | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM 180 mg; PM 180 mg | 84 ± 146 | — | — |
| Period 1: Day 5 AM 180 mg; PM 120 mg | 0 ± NA | — | — |
| Period 2: Day 5 | — | 179 ± 108 | — |
| Period 3: Week 24 | — | — | 202 ± 83 |
eGFR was calculated using Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula (mL/min/1.73m\^2) = 141 x min (SCr/K, 1)\^α x max(SCR /K,1)-1.209 x 0.993Age x 1.018 \[if female\] x 1.159 \[if Black\], where SCr is the serum creatinine (mg/dL), K = 0.7 for female and 0.9 for males, α is -0.329 for female and -0.411 for males.
| mL/min/1.73m^2 | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM (180 mg) | 91.1 ± 18.73 | — | — |
| Period 2: Day 5 AM | — | 90.6 ± 25.30 | — |
| Period 3: Week 24 | — | — | 82.0 ± 21.10 |
| picograms per milliliter (pg/mL) | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM (180 mg) | 25.8 ± 12.24 | — | — |
| Period 2: Day 5 AM | — | 30.5 ± 16.40 | — |
| Period 3: Week 24 | — | — | 31.2 ± 16.19 |
| mg/dL | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| ⦁ Magnesium - Period 1: Day 5 AM (180 mg) | 2.2 ± 0.36 | — | — |
| Magnesium - Period 2: Day 5 AM | — | 1.9 ± 0.28 | — |
| Magnesium - Period 3: Week 24 | — | — | 2.0 ± 0.20 |
| ⦁ Phosphorus - Period 1: Day 5 AM (180 mg) | 2.9 ± 0.39 | — | — |
| Phosphorus - Period 2: Day 5 AM | — | 3.1 ± 0.75 | — |
| Phosphorus - Period 3: Week 24 | — | — | 3.7 ± 0.52 |
| ⦁ Creatinine - Period 1: Day 5 AM (180 mg) | 0.93 ± 0.188 | — | — |
| Creatinine - Period 2: Day 5 AM | — | 0.94 ± 0.229 | — |
| Creatinine - Period 3: Week 24 | — | — | 1.01 ± 0.212 |
| mg/24hr | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Creatinine - Period 1: Day 5 AM 180 mg, PM 180 mg | 1454 ± 248 | — | — |
| Creatinine - Period 1: Day 5 AM 180 mg, PM 120 mg | 1190 ± NA | — | — |
| Creatinine - Period 2: Day 5 | — | 1408 ± 367 | — |
| Creatinine - Period 3: Week 24 | — | — | 1345 ± 373 |
| Phosphorus - Period 1: Day 5 AM 180 mg, PM 180 mg | 877 ± 353 | — | — |
| Phosphorus - Period 1: Day 5 AM 180 mg, PM 120 mg | 1100 ± NA | — | — |
| Phosphorus - Period 2: Day 5 | — | 962 ± 226 | — |
| Phosphorus - Period 3: Week 24 | — | — | 754 ± 240 |
| Magnesium - Period 1: Day 5 AM 180 mg, PM 180 mg | 104 ± 5 | — | — |
| Magnesium - Period 1: Day 5 AM 180 mg, PM 120 mg | 110 ± NA | — | — |
| Magnesium - Period 2: Day 5 | — | 161 ± 66 | — |
| Magnesium - Period 3: Week 24 | — | — | 121 ± 38 |
| Citrate - Period 1: Day 5 AM 180 mg, PM 180 mg | 662 ± 77 | — | — |
| Citrate - Period 1: Day 5 AM 180 mg, PM 120 mg | 778 ± NA | — | — |
| Citrate - Period 2: Day 5 | — | 381 ± 203 | — |
| Citrate - Period 3: Week 24 | — | — | 439 ± 224 |
| pH | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM 180 mg; PM 180 mg 0-24 hours post-dose | 6.2 ± 2.02 | — | — |
| Period 1: Day 5 AM 180 mg; PM 120 mg 0-24 hours post-dose | 5.0 ± NA | — | — |
| Period 2: Day 5 0-24 hours post-dose | — | 6.1 ± 0.68 | — |
| Period 3: Week 24 0-24 hours post-dose | — | — | 6.5 ± 0.69 |
| Milliequivalents (meq)/24hr | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Potassium Period 1: Day 5 AM 180 mg, PM 180 mg | 79.00 ± 48.662 | — | — |
| Potassium Period 1: Day 5 AM 180 mg, PM 120 mg | 82.00 ± NA | — | — |
| Potassium Period 2: Day 5 | — | 69.38 ± 24.476 | — |
| Potassium Period 3: Week 24 | — | — | 61.46 ± 32.196 |
| Sodium Period 1: Day 5 AM 180 mg, PM 180 mg | 186.33 ± 84.831 | — | — |
| Sodium Period 1: Day 5 AM 180 mg, PM 120 mg | 192.00 ± NA | — | — |
| Sodium Period 2: Day 5 | — | 184.77 ± 51.038 | — |
| Sodium Period 3: Week 24 | — | — | 182.23 ± 95.407 |
| nanomoles per deciliter (nmol/dL) | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM, 180 mg, PM 180 mg, 0-4 hours post-dose | 2.98 ± 0.795 | — | — |
| Period 1: Day 5, AM 180 mg, PM 120 mg 0-4 hours post-dose | 2.90 ± NA | — | — |
| Period 2: Day 5 0-4 hours post-dose | — | 2.79 ± 0.762 | — |
| Period 3: Week 24 0-4 hours post-dose | — | — | 2.68 ± 0.704 |
Blood samples were taken for analysis of bone resorption markers (CTx).
| Picograms per milliliter (pg/mL) | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM 180 mg | 386 ± 165 | — | — |
| Period 2: Day 5 AM | — | 266 ± 161 | — |
| Period 3: Week 24 | — | — | 744 ± 565 |
Blood samples were taken for analysis of bone formation markers (P1NP).
| Micrograms per liter (mcg/L) | Period 1: Encaleret | Period 2: Encaleret | Period 3: Encaleret |
|---|---|---|---|
| Period 1: Day 5 AM 180 mg | 27.33 ± 5.007 | — | — |
| Period 2: Day 5 AM | — | 26.8 ± 12.25 | — |
| Period 3: Week 24 | — | — | 103.7 ± 87.20 |
Collected over Up to 16 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1: Encaleret | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Periods 2 and 3: Encaleret | 0/13 (0%) | 0/13 (0%) | 13/13 (100%) |
| Event | Period 1: Encaleret | Periods 2 and 3: Encaleret |
|---|---|---|
| HypophosphataemiaMetabolism and nutrition disorders | 2/6 | 9/13 |
| HypercalcaemiaMetabolism and nutrition disorders | 0/6 | 6/13 |
| HypocalcaemiaMetabolism and nutrition disorders | 1/6 | 5/13 |
| Vulvovaginal mycotic infectionInfections and infestations | 0/3 | 3/8 |
| Upper respiratory tract infectionInfections and infestations | 0/6 | 4/13 |
| NauseaGastrointestinal disorders | 0/6 | 4/13 |
| ConstipationGastrointestinal disorders | 0/6 | 3/13 |
| DizzinessNervous system disorders | 0/6 | 3/13 |
| PharyngitisInfections and infestations | 1/6 | 1/13 |
| Iron deficiencyMetabolism and nutrition disorders | 1/6 | 0/13 |
Safety Analysis Set included all participants who received at least one dose of study drug in the considered period. As pre-specified, data were collected and are reported pooled for Period 1 and for Periods 2 and 3 combined.
| Age, Continuous(years) | Encaleret |
|---|---|
| Period 1 | 40.0 ± 17.65 |
| Periods 2 and 3 | 38.9 ± 14.90 |
| Sex: Female, Male(Participants) | Encaleret |
|---|---|
| Period 1 — Female | 3 |
| Period 1 — Male | 3 |
| Periods 2 and 3 — Female | 8 |
| Periods 2 and 3 — Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Encaleret |
|---|---|
| Period 1 — Hispanic or Latino | 0 |
| Period 1 — Not Hispanic or Latino | 6 |
| Period 1 — Unknown or Not Reported | 0 |
| Periods 2 and 3 — Hispanic or Latino | 0 |
| Periods 2 and 3 — Not Hispanic or Latino | 13 |
| Periods 2 and 3 — Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Encaleret |
|---|---|
| Period 1 — American Indian or Alaska Native | 0 |
| Period 1 — Asian | 0 |
| Period 1 — Native Hawaiian or Other Pacific Islander | 0 |
| Period 1 — Black or African American | 0 |
| Period 1 — White | 6 |
| Period 1 — More than one race | 0 |
| Period 1 — Unknown or Not Reported | 0 |
| Periods 2 and 3 — American Indian or Alaska Native | 0 |
| Periods 2 and 3 — Asian | 0 |
| Periods 2 and 3 — Native Hawaiian or Other Pacific Islander | 0 |
| Periods 2 and 3 — Black or African American | 0 |
| Periods 2 and 3 — White | 13 |
| Periods 2 and 3 — More than one race | 0 |
| Periods 2 and 3 — Unknown or Not Reported | 0 |
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Studies of the drug tested here: Encaleret
Hypercalciuric Hypocalcemia, Familial
Calcilytix Therapeutics, Inc., a BridgeBio company →