Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

NCT05164614 | Completed Phase 1

• 1 other identifier: CP-0004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single-center, open-label, phase I study evaluating the pharmacokinetics (PK) of human parathyroid hormone (1-34) ("PTH") administered via the RaniPill™ capsule ("RT-102").

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Forteo; Parathyroid Hormone; PTH

Outcome Measures

Primary Outcomes (3)

• Evaluate Cmax of PTH administered via the RaniPill capsule

  To obtain PK profiles of single doses of PTH given via RaniPill™ capsule in healthy participants with doses of 20 and 80 μg. Cmax of PTH will be calculated from the PK profiles.

  Within 24 hours after ingestion of the device

• Evaluate Tmax of PTH administered via the RaniPill capsule

  To obtain PK profiles of single doses of PTH given via RaniPill™ capsule in healthy participants with doses of 20 and 80 μg. Tmax of PTH will be calculated from the PK profiles.

  Within 24 hours after ingestion of the device

• Evaluate AUC of PTH administered via the RaniPill capsule

  To obtain PK profiles of single doses of PTH given via RaniPill™ capsule in healthy participants with doses of 20 and 80 μg. Absorption (AUC) of PTH will be calculated from the PK profiles.

  Within 24 hours after ingestion of the device

Secondary Outcomes (1)

• Safety and tolerability of RT-102

  Within 24 hours after ingestion of the device

Study Arms (5)

RT-102 Group 1

EXPERIMENTAL

In 15 subjects, a RaniPill capsule containing 20 µg of PTH will be administered and serial blood samples will be collected for PK analysis.

Combination Product: RT-102 (20 μg)

RT-102 Group 2

EXPERIMENTAL

In 15 subjects, a RaniPill capsule containing 80 µg of PTH will be administered and serial blood samples will be collected for PK analysis.

Combination Product: RT-102 (80 μg)

SC Group

ACTIVE COMPARATOR

In 10 subjects, 20 µg of Forteo will be administered subcutaneously and serial blood samples will be collected for PK analysis.

Drug: Forteo

Part 2; Group 1

EXPERIMENTAL

In up to 7 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy post-menopausal or surgically sterile with bilateral oophorectomy women.

Combination Product: RT-102 (20 μg)

Part 2; Group 2

EXPERIMENTAL

In up to 12 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy women.

Combination Product: RT-102 (20 μg)

Interventions

RT-102 (80 μg) COMBINATION_PRODUCT

RaniPill capsule containing PTH with doses of 20 and 80 μg

RT-102 Group 2

Forteo DRUG

A commercial formulation of PTH for SC control (20 µg)

SC Group

RT-102 (20 μg) COMBINATION_PRODUCT

RaniPill capsule containing PTH with dose of 20μg

Part 2; Group 1; Part 2; Group 2; RT-102 Group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1
• Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
• Willing to comply with all study procedures and available for the entire duration of the study
• Participant is ambulatory female between 18 to 65 years of age.
• BMI between 19 to 32 kg/m2.
• In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
• Non-menstruating, non-pregnant or non-lactating women during study participation NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening. Contraception (double barrier contraception and be protected by a daily combination birth control pill containing estrogen and progestin or any other form of hormonal contraceptive if cannot use the contraceptive pill) should be used between Screening visit and 30 days after dosing if actively engaged in penile-vaginal intercourse.
• Part 2: Healthy Women
• Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
• Willing to comply with all study procedures and available for the entire duration of the study
• Participant is ambulatory female between 18 to 65 years of age.
• BMI between 19 to 32 kg/m2.
• In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
• Non-menstruating, non-pregnant or non-lactating women during study participation NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening. A double barrier approach using highly effective methods of contraception (e.g., oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system \[e.g., Mirena\], progestogen-only hormonal contraception associated with inhibition of ovulation, nonhormonal intrauterine device, bilateral tubal occlusion) should be used between Screening visit and 30 days after dosing if actively engaged in penile-vaginal intercourse.
• Part 2: Post-menopausal/surgically sterile

You may not qualify if:

• Part 1
• Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
• Participant has known history of intolerance of PTH (1-34)
• Participant has known history of high levels of uric acid outside normal ranges
• Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)
• Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year
• Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)
• Participant has febrile illness within 30 days of the study procedures
• Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
• Participant currently treated with intravenous bisphosphonates for at least 1 month or oral bisphosphonates within the past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the treatment occurred 6 or more months prior to enrollment
• Participants on a regimen of proton pump inhibitors (e.g. omeprazole) or histamine H2 receptor antagonists (e.g. ranitidine)
• Participants with known bowel obstruction/stricture/fistula
• Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)
• Participants who have undergone a recent (less than a month) barium X-ray procedure
• Participants with known allergies or sensitivity to contrast media or barium sulfate

Sponsors & Collaborators

• RANI Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

MeSH Terms

Interventions

Teriparatide

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Joshua Myers

  RANI Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy women volunteers

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 20, 2021
• Study Start: February 21, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 17, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)