Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

• Status: Not yet recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: Female

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").

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RANI Therapeutics
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

Part 1

1. Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures

2. Willing to comply with all study procedures and available for the entire duration of the study

3. Participant is ambulatory female between 18 to 65 years of age.

4. BMI between 19 to 32 kg/m2.

5. In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.

6. 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

1. Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures

2. Willing to comply with all study procedures and available for the entire duration of the study

3. Healthy ambulatory female post-menopausal for at least 1 year or surgically sterile with bilateral oophorectomy

4. BMI between 19 to 32 kg/m2.

5. In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.

Exclusion Criteria:

Part 1

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

2. Participant has known history of intolerance of PTH (1-34)

3. Participant has known history of high levels of uric acid outside normal ranges

4. Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)

5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year

6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)

7. Participant has febrile illness within 30 days of the study procedures

8. Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)

9. 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

10. Participants on a regimen of proton pump inhibitors (e.g. omeprazole) or histamine H2 receptor antagonists (e.g. ranitidine)

11. Participants with known bowel obstruction/stricture/fistula

12. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)

13. Participants who have undergone a recent (less than a month) barium X-ray procedure

14. Participants with known allergies or sensitivity to contrast media or barium sulfate

15. Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes

16. Participants with congestive heart failure, renal failure

17. Presence of cardiac pacemaker or implanted electromedical device

18. Participant who is pregnant or lactating

19. Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer

20. Participant received COVID-19 vaccine within 7 days of dosing

21. Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan

22. Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk

Part 2

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

2. Participant has known history of intolerance of PTH (1-34)

3. Participant has known history of high levels of uric acid outside normal ranges

4. Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)

5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year

6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)

7. Participant has febrile illness within 30 days of the study procedures

8. Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)

9. 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

10. Participants on a regimen of proton pump inhibitors (e.g. omeprazole) or histamine H2 receptor antagonists (e.g. ranitidine)

11. Participants with known bowel obstruction/stricture/fistula

12. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)

13. Participants who have undergone a recent (less than a month) barium X-ray procedure

14. Participants with known allergies or sensitivity to contrast media or barium sulfate

15. Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes

16. Participants with congestive heart failure, renal failure

17. Presence of cardiac pacemaker or implanted electromedical device

18. Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer

19. Participant received COVID-19 vaccine within 7 days of dosing

20. Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan

21. Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk