A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults
CompletedPhase 1Results postedLast updated 15 December 2023
What this trial tests
Phase 1 trial testing rhPTH(1-84) in Healthy Volunteers in 96 participants. Completed in 15 April 2022.
Adults 18 to 65, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part I: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84)Primary· Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose
AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration.
Group
Value
95% CI
Part I: Treatment A
471.9
± 57.4
Part I: Treatment B
603.1
± 50.3
Part II: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84)Primary· Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose
AUClast was a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration.
Group
Value
95% CI
Part II: Treatment C
44.34
± 161.7
Part II: Treatment D
97.74
± 123.4
Part II: Treatment E
259.2
± 57.5
Part II: Treatment F
1009
± 61.3
Part I: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84)Primary· Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose
AUCinf was the area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration. AUC was be used as a measure of drug exposure. It was derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Group
Value
95% CI
Part I: Treatment A
559.7
± 53.2
Part I: Treatment B
663.7
± 44.0
Part II: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84)Primary· Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose
AUCinf was the area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration. AUC was be used as a measure of drug exposure. It was derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Group
Value
95% CI
Part II: Treatment C
83.91
± 19.5
Part II: Treatment D
217.0
± 33.2
Part II: Treatment E
364.7
± 39.0
Part II: Treatment F
1117
± 59.6
Part I: Maximum Observed Plasma Concentration (Cmax) of rhPTH(1-84)Primary· Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose
Cmax referred to the maximum (or peak) concentration that a drug achieved in the body after the drug had been administrated.
Group
Value
95% CI
Part I: Treatment A
150.8
± 53.2
Part I: Treatment B
185.1
± 52.7
Part II: Maximum Observed Plasma Concentration (Cmax) of rhPTH(1-84)Primary· Pre-dose, 0.08, 0.16, 0.33, 0.5, 0.75, 1.0, 1.25,1.5,2.0, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours post dose
Cmax referred to the maximum (or peak) concentration that a drug achieved in the body after the drug had been administrated.
Group
Value
95% CI
Part II: Treatment C
28.05
± 50.4
Part II: Treatment D
43.06
± 47.5
Part II: Treatment E
77.46
± 55.8
Part II: Treatment F
250.2
± 41.5
Part I and II: Number of Participants With Treatment Emergent Adverse Events (TEAEs)Secondary· From start of study drug administration up to Day 34
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. Number of participants with TEAEs was reported.
Group
Value
95% CI
Part I: Treatment A
19
Part I: Treatment B
15
Part II: Treatment C
2
Part II: Treatment D
4
Part II: Treatment E
3
Part II: Treatment F
2
Number of Participants With Clinically Significant Changes in Vital Signs ValuesPrimary· From start of study drug administration up to Day 34
Vital sign assessments included systolic and diastolic blood pressure, pulse rate and body temperature. Any change in vital signs which are deemed clinically significant by the investigator were reported.
Group
Value
95% CI
Part I: Treatment A
1
Part I: Treatment B
0
Part II: Treatment C
0
Part II: Treatment D
0
Part II: Treatment E
0
Part II: Treatment F
0
Part I and II: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters Reported as TEAEsSecondary· From start of study drug administration up to Day 34
Any change in ECG assessments which were deemed clinically significant by the investigator were reported.
Group
Value
95% CI
Part I: Treatment A
0
Part I: Treatment B
0
Part II: Treatment C
0
Part II: Treatment D
0
Part II: Treatment E
0
Part II: Treatment F
0
Part I and II: Number of Participants With Clinically Significant Changes in Clinical Laboratory ValuesSecondary· From start of study drug administration up to Day 34
Clinical laboratory tests included hematology, chemistry, and urinalysis. Any changes in clinical laboratory results which are deemed clinically significant by the investigator were reported.
Group
Value
95% CI
Part I: Treatment A
0
Part I: Treatment B
0
Part II: Treatment C
1
Part II: Treatment D
1
Part II: Treatment E
0
Part II: Treatment F
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study drug administration up to Day 34.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the main aim is to assess the dose linearity of the new formulation.
Participants will receive 2 doses in Part I and 4 doses in Part II.
Participants need to visit their doctor approximately 14 days and 30 days after the last dose of study drug.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
· Phase 3
· withdrawn
NCT03364738 — Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism
· Phase 3
· terminated
NCT03150108 — Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects
· Phase 1
· completed
NCT02910466 — A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism
· Phase 4
· completed
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Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 15 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05137730.