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Healthy VolunteersPhase 1NCT05164614

Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

A Phase 1 study testing RT-102 (80 μg), Forteo and RT-102 (20 μg) in people with Healthy Volunteers, run by RANI Therapeutics at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
RT-102 (80 μg), Forteo and RT-102 (20 μg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteAustralia
Study dates
21 Feb 2022to 17 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 70Show fewer
  • 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
  • Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
  • Participants with congestive heart failure, renal failure
  • Presence of cardiac pacemaker or implanted electromedical device
  • Participant who is pregnant or lactating
  • 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
  • Participant received COVID-19 vaccine within 7 days of dosing
  • Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
  • Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk
  • Part 2: Healthy Women
  • 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 higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 8.3.9 for details)
  • Participants on a 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
  • Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
  • Participants with congestive heart failure, renal failure
  • Presence of cardiac pacemaker or implanted electromedical device
  • Participant who is pregnant or lactating
  • 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
  • Participant received COVID-19 vaccine within 7 days of dosing
  • Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
  • Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk
  • Part 2: Post-menopausal/surgically sterile
  • 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 higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 8.3.9 for details)
  • Participants on a 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
  • Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
  • Participants with congestive heart failure, renal failure
  • Presence of cardiac pacemaker or implanted electromedical device
  • 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
  • Participant received COVID-19 vaccine within 7 days of dosing
  • Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
  • Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network

    Melbourne

Other trials in Australia

About this study

Official title: A Phase I Study to Evaluate the Pharmacokinetics of Parathyroid Hormone (1-34) Administered Orally Via RaniPill™ Capsule

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").

Read the detailed description

The RaniPill device is a capsule-like ingestible device, which injects a microneedle containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center, prospective, open-label, feasibility study being conducted in two parts.

Part 1: Healthy women volunteers, 18-65 years of age, of any race, recruited from the general population and assigned to one of the following groups:

RT-102:

  • RT-102 Group 1: 20 µg (N=15)
  • RT-102 Group 2: 80 µg (N=15)

Subcutaneous (SC):

  • SC Group: 20 µg of Forteo (N=10)

Part 2: Healthy women, 18-65 years of age, or healthy post-menopausal or surgically sterile with bilateral oophorectomy women of any race, recruited from the general population will have once-a-day repeat dosing with 20 μg dose of RT-102 for 7 days (N= up to 12):

  • Healthy women: N = up to 12
  • Post-menopausal or surgically sterile volunteers: N = up to 7
Being tested
RT-102 (80 μg), Forteo, RT-102 (20 μg)
Keywords
Healthy Volunteers, Forteo, Parathyroid Hormone, PTH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RT-102 (80 μg)Combination product

    RaniPill capsule containing PTH with doses of 20 and 80 μg

  • ForteoDrug

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

  • RT-102 (20 μg)Combination product

    RaniPill capsule containing PTH with dose of 20μg

Study groups in NCT05164614
Study groupRoleWhat they receive
RT-102 Group 1ExperimentalIn 15 subjects, a RaniPill capsule containing 20 µg of PTH will be administered and serial blood samples will be collected for PK analysis.
Receives: Combination Product: RT-102 (20 μg)
RT-102 Group 2ExperimentalIn 15 subjects, a RaniPill capsule containing 80 µg of PTH will be administered and serial blood samples will be collected for PK analysis.
Receives: Combination Product: RT-102 (80 μg)
SC GroupActive comparatorIn 10 subjects, 20 µg of Forteo will be administered subcutaneously and serial blood samples will be collected for PK analysis.
Receives: Drug: Forteo
Part 2; Group 1ExperimentalIn 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.
Receives: Combination Product: RT-102 (20 μg)
Part 2; Group 2ExperimentalIn up to 12 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy women.
Receives: Combination Product: RT-102 (20 μg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 24 hours after ingestion of the device

  2. 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.

    Measured: Within 24 hours after ingestion of the device

  3. 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.

    Measured: Within 24 hours after ingestion of the device

Secondary outcomes (1)

  1. Safety and tolerability of RT-102

    Monitoring and recording of adverse events possibly related to RT-102.

    Measured: Within 24 hours after ingestion of the device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start21 Feb 2022
  3. Primary completion10 Oct 2022
  4. Study completion17 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Healthy women volunteers
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164614
Sponsor's protocol ID
CP-0004
Status last verified
Oct 2022
First submitted
1 Dec 2021
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RT-102 (80 μg), Forteo and RT-102 (20 μg) in people with Healthy Volunteers, run by RANI Therapeutics at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 70 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Cmax of PTH administered via the RaniPill capsule (time frame: Within 24 hours after ingestion of the device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05164614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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