Phase 1
Completed N=84
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
Healthy Volunteers
Source: ClinicalTrials.gov NCT05137730 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Part I: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84) — 471.9; 603.1 picogram*hour/milliliter (pg*hr/ml)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part I: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84) |
471.9; 603.1 | — |
| PRIMARY Part II: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of rhPTH (1-84) |
44.34; 97.74; 259.2; 1009 | — |
| PRIMARY Part I: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84) |
559.7; 663.7 | — |
| PRIMARY Part II: Area Under the Plasma Concentration- Time Curve From Time Zero to Infinity (AUCinf) of rhPTH(1-84) |
83.91; 217.0; 364.7; 1117 | — |
| PRIMARY Part I: Maximum Observed Plasma Concentration (Cmax) of rhPTH(1-84) |
150.8; 185.1 | — |
| PRIMARY Part II: Maximum Observed Plasma Concentration (Cmax) of rhPTH(1-84) |
28.05; 43.06; 77.46; 250.2 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs Values |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Part I and II: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
19; 15; 2; 4; 3; 2 | — |
| SECONDARY Part I and II: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters Reported as TEAEs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part I and II: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values |
0; 0; 1; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study:
- Healthy, adult, male or female, 18-65 years of age, inclusive, at screening. Attempts will be made to enroll at least 20% of each sex in each study part.
- Continuous non-smoker who has not used nicotine containing products for at least 90 days prior to the first dosing and throughout the study, based on participant self-reporting.
- Body mass index (BMI) greater than or equal to (>=) 18.5 and less than or equal to ( = 89/49 millimeters of mercury (mmHg) and =40 bpm and = 80 milliliter per minute (mL/minute) at screening.
- Agrees to comply with any applicable contraceptive requirements of the protocol.
- Understands the study procedures in the ICF, be able to voluntarily provide written, signed, and dated informed consent, and be willing and able to comply with the protocol.
Exclusion Criteria
Participants must not be enrolled in the study if they meet any of the following criteria:
- Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study in the opinion of the Investigator or designee.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
- History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the study drug, or clinical or laboratory assessments.
- Participants who are at increased baseline risk for osteosarcoma such as participants with Paget's disease of bone or unexplained elevations of alkaline phosphatase (ALP), hereditary disorders predisposing to osteosarcoma or a prior history of external beam or implant radiation therapy involving the skeleton.
- History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History or presence of alcoholism or drug abuse, in the opinion of the Investigator or designee, within the past 2 years prior to the first dosing.
- Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day. (1 alcohol unit=1 beer or 1 wine (5 ounces (oz)/150 in milliliters (mL) or 1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol).
- Positive urine drug or alcohol results at screening or check-in.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
- History of abnormalities of calcium homeostasis including hyperparathyroidism, hypoparathyroidism, hyperthyroidism, Cushing's syndrome, hypercalcemia, hypocalcemia, osteoporosis, or any other calcium disorder.
- Female participants who have a positive pregnancy test or who are lactating.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Has tattoo(s) or scarring at or near the site of injection or any other condition which may interfere with injection site examination, in the opinion of the Investigator or designee.
- Routine consumption of more than 2 units of caffeine per day or participants who experience caffeine withdrawal headaches. A unit of caffeine is contained in the following items: one 6 oz (180 mL) cup of coffee, two 12 oz (360 mL) cans of cola, one 12 oz cup of tea, three 1 oz (85 g) chocolate bars.
- Prior screen failure, randomization, participation, or enrollment in this study or prior exposure to any exogenous PTH, PTH fragments or analogs 3 months prior to dosing with rhPTH(1-84).
- Unable to refrain from or anticipates the use of any medication or substance (including
Data sourced from ClinicalTrials.gov (NCT05137730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.